MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2017-03-02 for ALEVE DIRECT THERAPY TENS 1613538 manufactured by Bayer Healthcare Llc, Consumer Care.
[68964101]
This spontaneous case was reported by a consumer and describes the occurrence of chemical injury ("they looked like chemical burns/ they looked like burns/the burn was very bad") in a male patient who received aleve tens device direct therapy unit. Other product or product use issues identified: device leakage "he said that whatever is in the gel that leaked out must have reacted with my skin," and therapeutic response unexpected "the unit had helped me reduce my opioid use". The patient's concurrent conditions included spinal fusion nos. On an unknown date, the patient started aleve tens device direct therapy unit at an unspecified dose and frequency. In 2016, the patient experienced chemical injury (seriousness criteria medically significant and clinically significant/intervention required) with urticaria and scab. The patient was treated with neosporin (neosporin topical). Aleve tens device direct therapy unit was interrupted. At the time of the report, the chemical injury outcome was unknown. The reporter considered chemical injury to be related to aleve tens device direct therapy unit. The reporter commented: i replaced the pads for about the 10th time, put them on and laid down. I had it on level 3 or 4, not to high, and the events occurred. Quality-safety evaluation of ptc: (b)(4): unconfirmed quality defect: risk category v. Final assessment: per global (b)(4), if no sample are available and no batch data of the medical product or medical device have been reported in the complaint, it is closed without further investigation. Medical assessment: a ptc investigation can not be initiated as a batch number or sample was not provided thus resulting in an unconfirmed quality defect. (b)(4): unconfirmed quality defect: risk category v. Final assessment : batch documentation has been reviewed by bayer quality assurance. All deviations and non-conformances have also been reviewed by bayer quality assurance to identify potential product quality concerns, with non identified for the applicable lot. Without a return sample, no further investigation is possible. This issue will be monitored and treated to potentially identify new failure modes. Medical assessment: based on the information available, batch documentation was received and no product quality concerns were identified, however, since no sample was provided no final assessment is possible thus resulting in an outcome of unconfirmed quality defect. Most recent follow-up information incorporated above includes: on 1-mar-2017: ptc investigation result received. Unconfirmed quality defect: risk category v. Company causality comment: this spontaneous case, reported by a consumer,describes the occurrence of serious event chemical injury ("they looked like chemical burns/ they looked like burns/the burn was very bad")(medically significant and intervention required ) in a male patient who received aleve tens device direct therapy unit for a not reported indication. This event is unlisted according to aleve tens reference safety information. The patient's concurrent conditions included spinal fusion nos. Patient replaced the pads for about the 10th time, put them on and laid down, had the device on level 3 or 4, and reported non-serious device leakage ("he said that whatever is in the gel that leaked out must have reacted with my skin") followed by chemical injury. In this context, considering the technical issue and the close temporal relationship, causality of aleve tens cannot be excluded, in agreement with reporter.
Patient Sequence No: 1, Text Type: D, B5
[71012426]
Most recent follow-up information incorporated above includes: on 28-feb-2017: quality safety evaluation: unconfirmed quality defect: risk category v. Company causality comment: this spontaneous case, reported by a consumer,describes the occurrence of serious event chemical injury ("they looked like chemical burns/ they looked like burns/the burn was very bad")(medically significant and intervention required ) in a male patient who received aleve tens device direct therapy unit for a not reported indication. This event is unlisted according to aleve tens reference safety information. The patient's concurrent conditions included spinal fusion nos. Patient replaced the pads for about the 10th time, put them on and laid down, had the device on level 3 or 4, and reported non-serious device leakage ("he said that whatever is in the gel that leaked out must have reacted with my skin") followed by chemical injury. In this context, considering the technical issue and the close temporal relationship, causality of aleve tens cannot be excluded, in agreement with reporter. Ptc investigation: unconfirmed quality defect.
Patient Sequence No: 1, Text Type: D, B5
[117963057]
This spontaneous case was reported by a consumer and describes the occurrence of first degree chemical burn of skin ("they looked like chemical burns/ they looked like burns/the burn was very bad/ they were first, second and third degree burns"), second degree chemical burn of skin ("they looked like chemical burns/ they looked like burns/the burn was very bad/ they were first, second and third degree burns") and third degree chemical burn of skin ("they looked like chemical burns/ they looked like burns/the burn was very bad/ they were first, second and third degree burns") in a male patient who received aleve tens device direct therapy unit (batch no. Unk). Other product or product use issues identified: device leakage "he said that whatever is in the gel that leaked out must have reacted with my skin," in 2016, contraindicated device used "titanium plates as well as a ton of rods and screws on lower back" and therapeutic response unexpected "the unit had helped me reduce my opioid use". The patient's concurrent conditions included spinal fusion nos since 2014 and internal fixation of spine. On an unknown date, the patient started aleve tens device direct therapy unit. In 2016, the patient experienced first degree chemical burn of skin (seriousness criteria medically significant and intervention required) with urticaria, scab, pruritus and skin ulcer, second degree chemical burn of skin (seriousness criteria medically significant and intervention required) with urticaria, scab, pruritus and skin ulcer and third degree chemical burn of skin (seriousness criteria medically significant and intervention required) with urticaria, pruritus, scab and skin ulcer. The patient was treated with neosporin (neosporin topical). Aleve tens device direct therapy unit was interrupted. At the time of the report, the first degree chemical burn of skin, second degree chemical burn of skin and third degree chemical burn of skin had resolved. The reporter considered first degree chemical burn of skin, second degree chemical burn of skin and third degree chemical burn of skin to be related to aleve tens device direct therapy unit. The reporter commented: i replaced the pads for about the 10th time, put them on and laid down. I had it on level 3 or 4, not to high, and the events occurred. Consumer used the product before for about 3 months with no issues. Quality-safety evaluation of ptc: (b)(4): unconfirmed quality defect: risk category v. Per global sop 115, if no sample are available and no batch data of the medical product or medical device have been reported in the complaint, it is closed without further investigation. A ptc investigation can not be initiated as a batch number or sample was not provided thus resulting in an unconfirmed quality defect. (b)(4): unconfirmed quality defect: risk category v. Batch documentation has been reviewed by bayer quality assurance. All deviations and non-conformances have also been reviewed by bayer quality assurance to identify potential product quality concerns, with non identified for the applicable lot. Without a return sample, no further investigation is possible. This issue will be monitored and treated to potentially identify new failure modes. Based on the information available, batch documentation was received and no product quality concerns were identified, however, since no sample was provided no final assessment is possible thus resulting in an outcome of unconfirmed quality defect. Most recent follow-up information incorporated above includes: on 27-jun-2017: the previously reported event they looked like chemical burns/ they looked like burns/the burn was very bad was reworked to they looked like chemical burns/ they looked like burns/the burn was very bad /they were first, second and third degree burns and open sores on back and itching on sores were added as symptom for this event; event titanium plates as well as a ton of rods and screws on lower back was also added; medical history updated. Company causality comment: this spontaneous case, reported by a consumer, describes the occurrence of serious events chemical injury- first degree burns, second degree burns and third degree burns ("they looked like chemical burns/ they looked like burns/the burn was very bad") (medically significant and intervention required) in a male patient who received aleve tens device direct therapy unit for a not reported indication. This events are unlisted according to aleve tens reference safety information. The patient's concurrent conditions included spinal fusion nos. Patient replaced the pads for about the 10th time, put them on and laid down, had the device on level 3 or 4, and reported non-serious device leakage ("he said that whatever is in the gel that leaked out must have reacted with my skin") followed by chemical injury. In this context, considering the technical issue and the close temporal relationship, causality of aleve tens cannot be excluded, in agreement with reporter. Ptc investigation: unconfirmed quality defect.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020060-2017-00003 |
| MDR Report Key | 6373325 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2017-03-02 |
| Date of Report | 2018-02-15 |
| Date of Event | 2016-01-01 |
| Date Mfgr Received | 2018-02-05 |
| Date Added to Maude | 2017-03-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. K. SHAW LAMBERSON |
| Manufacturer Street | 100 BAYER BLVD. P.O. BOX 915 |
| Manufacturer City | WHIPPANY NJ 079810915 |
| Manufacturer Country | US |
| Manufacturer Postal | 079810915 |
| Manufacturer G1 | BAYER HEALTHCARE LLC, CONSUMER CARE |
| Manufacturer Street | 36 COLUMBIA RD. |
| Manufacturer City | MORRISTOWN NJ 07960 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07960 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALEVE DIRECT THERAPY TENS |
| Generic Name | STIMULATOR, NERVE, TRANSCUTANEOUS, ELECTRICAL NERVE STIMULATOR (TENS) |
| Product Code | NUH |
| Date Received | 2017-03-02 |
| Model Number | 1613538 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAYER HEALTHCARE LLC, CONSUMER CARE |
| Manufacturer Address | 36 COLUMBIA RD. MORRISTOWN NJ 07960 US 07960 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-03-02 |