MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-09-07 for ICY HOT SMART RELIEF TENS BACK PAIN THERAPY manufactured by Chattem.
[85139713]
Based on additional information received on 08-aug- 2017, this case was upgraded to serious from nonserious (events of piece of skin came off described as closer to the size of a dime, had stinging, application site burning were added, seriousness criteria: important medical event was added) initial information regarding this unsolicited case from united states was received from a non-healthcare professional on 04-aug-2017. This case involves a female patient of unspecified age, whose piece of skin came off described as closer to the size of a dime, had stinging, application site burning (reported as burn-thermal) after started using smart relief tens therapy (icy hot smart relief tens back pain therapy). The patient had back surgery on l4, l5 and s1 (lower region half way over by her hip) in 1992 and again in 2001 prior to use of the device. Past drugs and concomitant medications were not reported. On unknown date, the patient used smart relief tens therapy at an unspecified frequency (lot/batch number: 178105 and expiry date: 31-may-2019) for back pain. Electrode pad lot number: b-16-09-12, expiry date: 31- may-2019, serial number: (b)(4). Reportedly, the patient had a burn thermal on (b)(6) 2017 (latency: unknown), after using the smart relief tens therapy. The reporter stated the event was related to burns. The patient's piece of skin came off and had stinging (onset date and latency: unknown) burning sensation after starting smart relief tens therapy. The patient bought it and she used it when she got home last night between 2:30 am and 3:00 am. The reporter used the device in a rolling desk chair. The reporter touched the device and could feel the sensation when the patient went to remove the electrode pad, she noticed a burning sensation. She also noticed a stinging burning sensation. After taking the device off, a piece of her skin came off, described as closer to the size of a dime (onset date and latency: unknown). She had checked the electrode pad was unable to locate the piece of skin. The reporter provided the device was placed above her butt check halfway across the spine to the hip on the right side, about where the waistline was for jeans. It was verified that the device was not placed over the spine. Action taken: unknown. Corrective treatment: not reported. Outcome: unknown for all the events. Seriousness criteria: important medical event for all the events additional information was received on 08-aug-2017, this case was upgraded to serious from non-serious (events of piece of skin came off described as closer to the size of a dime, had stinging, application site burning were added, seriousness criteria: important medical event was added). Event verbatim updated to burn-thermal. Lot batch details and gender updated. Medical history added. Clinical course updated. Text amended accordingly.
Patient Sequence No: 1, Text Type: D, B5
[85934448]
The case ((b)(6)) was found to be a duplicate to the case ((b)(6)). Hence the case (b)(6) qualifies for deletion. The additional information of the case (b)(6) has been incorporated in the active case. Based on additional information received on 08-aug- 2017, this case was upgraded to serious from nonserious (events of piece of skin came off described as closer to the size of a dime, had stinging, application site burning were added, seriousness criteria: important medical event was added) initial information regarding this unsolicited case from united states was received from a non-healthcare professional on 04-aug-2017. This case involves a female patient of unspecified age, whose piece of skin came off described as closer to the size of a dime (tissue damage), had stinging, application site burning (reported as burn-thermal) after started using smart relief tens therapy (icy hot smart relief tens back pain therapy). The patient had back surgery on l4, l5 and s1 (lower region half way over by her hip) in 1992 and again in 2001 prior to use of the device. Past drugs and concomitant medications were not reported. On unknown date, the patient used smart relief tens therapy at an unspecified frequency (lot/batch number: 178105 and expiry date: 31-may-2019) for back pain. Electrode pad lot number: b-16-09-12, expiry date: 31-may- 2019, serial number: (b)(4). Reportedly, the patient had a burn thermal on (b)(6) 2017 (latency: unknown), after using the smart relief tens therapy. The reporter stated the event was related to burns. The patient's piece of skin came off and had stinging (onset date and latency: unknown) burning sensation after starting smart relief tens therapy. The patient bought it and she used it when she got home last night between 2:30 am and 3:00 am. The reporter used the device in a rolling desk chair. The reporter touched the device and could feel the sensation when the patient went to remove the electrode pad, she noticed a burning sensation. She also noticed a stinging burning sensation. After taking the device off, a piece of her skin came off, described as closer to the size of a dime (onset date and latency: unknown). She had checked the electrode pad was unable to locate the piece of skin. The reporter provided the device was placed above her butt check halfway across the spine to the hip on the right side, about where the waistline was for jeans. It was verified that the device was not placed over the spine. Patient had tissue damage and experienced burn-thermal. Qa review was performed and investigation findings were reported as 'this product meets the monograph standard. All specifications have been met and quality reports do not reveal any issues with this product. Complaints pertaining to consumer adverse events are trended and presented to management monthly. In the absence of the product formulation, lot number, and complaint sample; no further qa investigation is possible. ' action taken: unknown. Corrective treatment: not reported. Outcome: unknown for all the events. Reporter causality description: related seriousness criteria: important medical event for all the events additional information was received on 08-aug-2017, this case was upgraded to serious from non-serious (events of piece of skin came off described as closer to the size of a dime, had stinging, application site burning were added, seriousness criteria: important medical event was added). Event verbatim updated to burn-thermal. Lot batch details and gender updated. Medical history added. Clinical course updated. Text amended accordingly. Additional information was received from a consumer and the quality department on 10-aug-2017: event verbatim updated to piece of skin came off described as closer to the size of a dime (tissue damage). Qa finding added. The case ((b)(6)) was found to be a duplicate to the case ((b)(6)). Hence the case (b)(6) qualifies for deletion. The additional information of the case (b)(6) has been incorporated in the active case. Text amended accordingly. Pharmacovigilance comment: sanofi company comment dated 10-08-2017:this case concerns a female patient who experienced exfoliation at application site whilst being on the device smart relief tens therapy. The causal role of suspect device cannot be ruled out , however this case lacks information regarding the condition of the skin at the contact area prior to applying the device if wet, dry or open wounds and furthermore the pictures of the burn area which are yet not available would provide the comprehensive assessment of the case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1022556-2017-00006 |
| MDR Report Key | 6848815 |
| Report Source | CONSUMER |
| Date Received | 2017-09-07 |
| Date of Report | 2017-08-04 |
| Date Mfgr Received | 2017-08-08 |
| Date Added to Maude | 2017-09-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | HEATHER SCHIAPPACASSE |
| Manufacturer Street | 55 CORPORATE DRIVE 55B-220A |
| Manufacturer City | BRIDGEWATER NJ 08807 |
| Manufacturer Country | US |
| Manufacturer Postal | 08807 |
| Manufacturer Phone | 9089817289 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICY HOT SMART RELIEF TENS BACK PAIN THERAPY |
| Generic Name | TRANSCUTANEOUS NERVE STIMULATOR |
| Product Code | NUH |
| Date Received | 2017-09-07 |
| Lot Number | 178105 |
| Device Expiration Date | 2019-05-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHATTEM |
| Manufacturer Address | 1715 WEST 38TH STREET CHATTANOOGA TN 37409 US 37409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-07 |