MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-01-31 for ICY HOT SMART RELIEF TENS BACK PAIN THERAPY manufactured by Chattem.
[66157954]
Initial information regarding this unsolicited case from united states was received on 22-jan-2017 from the patient. This case involves a female patient of unknown age who had terrible blisters on her back, an unknown duration after initiating treatment with smart relief tens therapy (icy hot smart relief tens back pain therapy). No past drugs, relevant medical history, concurrent conditions or concomitant medications were reported. On an unspecified date, the patient started using smart relief tens therapy (frequency, lot/batch number and expiration date: unknown) for back pain. According to the patient, it released some of the pain. It was for back and hip. On an unknown date, the patient put it on her back and pushed the plus and sat in the chair. She immediately felt like something poking her in the back. She removed the patch and observed terrible blisters on her back (latency: unspecified). The patient had been in pain from this. Action taken: unknown. Corrective treatment: not reported. Outcome: unknown. Seriousness criteria: important medical event.
Patient Sequence No: 1, Text Type: D, B5
[66703968]
Initial information regarding this unsolicited case from united states was received on 22-jan-2017 from the patient. This case involves a female patient of unknown age who had terrible blisters on her back, an unknown duration after initiating treatment with smart relief tens therapy (icy hot smart relief tens back pain therapy). No past drugs, relevant medical history, concurrent conditions or concomitant medications were reported. On an unspecified date, the patient started using smart relief tens therapy (frequency, lot/batch number and expiration date: unknown) for back pain. According to the patient, it released some of the pain. It was for back and hip. On an unknown date, the patient put it on her back and pushed the plus and sat in the chair. She immediately felt like something poking her in the back. She removed the patch and observed terrible blisters on her back (latency: unspecified). The patient had been in pain from this. Action taken: unknown. Corrective treatment: not reported. Outcome: unknown. Seriousness criteria: important medical event. Qa review findings: the consumer stated that they experienced painful blisters after using the device on their back. A thorough investigation ((b)(4), capa protocol and review of ihsr [2014]) has been done to investigate the likelihood of the ihsr producing burns in some users. This investigation found that it is highly unlikely for the smart relief to produce tissue trauma. The maximum current and power density calculated for the smart relief is a tiny fraction of the limits in the fda guidance. The complete investigation is located in the device files. Lot information was not provided at this time. Awaiting further correspondence and device return for additional investigation. Additional information was received on 25-jan-2017 from quality department, qa review finding added. Text amended accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1022556-2017-00001 |
| MDR Report Key | 6289732 |
| Report Source | CONSUMER |
| Date Received | 2017-01-31 |
| Date of Report | 2017-01-22 |
| Date Mfgr Received | 2017-01-25 |
| Date Added to Maude | 2017-01-31 |
| 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 |
| 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 | 2017-01-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-01-31 |