MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-09-28 for SMART RELIEF TENS THERAPY BACK manufactured by Chattem.
[87591903]
Initial information regarding this unsolicited case from united states was received from a patient on (b)(6) 2017. This case concerns a female patient of unspecified age who had blistered, skin coming off, burns and skin was raw after using smart relief tens therapy (smart relief tens therapy back). She had implanted teeth (metallic implant). No past drugs and concomitant medication were reported. On an unknown date, the patient commenced therapy with smart relief tens therapy at an unspecified frequency (lot/batch number: 17e111 and expiry date: 31-jul-2019; indication not reported). The control unit serial number: (b)(4). The patient had burns after using the smart relief tens. It was reported that her skin was raw and blistered with skin coming off her hip (onset date and latency not reported for all events) after using the smart relief tens therapy. She went to the doctor and he gave her some medicinal ointment and bandaged the area (corrective treatment for application site peeling and skin texture abnormal). Action taken: permanently discontinued. Corrective treatment: medical ointment for burns and blisters. Outcome: unknown. Seriousness criteria: important medical history (blistered, burn and skin coming off).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1022556-2017-00008 |
| MDR Report Key | 6899945 |
| Report Source | CONSUMER |
| Date Received | 2017-09-28 |
| Date of Report | 2017-09-13 |
| Date of Event | 2017-09-10 |
| Date Mfgr Received | 2017-11-10 |
| Date Added to Maude | 2017-09-28 |
| 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 | SMART RELIEF TENS THERAPY BACK |
| Generic Name | TRANSCUTANEOUS NERVE STIMULATOR |
| Product Code | NUH |
| Date Received | 2017-09-28 |
| Returned To Mfg | 2017-11-09 |
| Lot Number | 17E111 |
| Device Expiration Date | 2019-07-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| 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 | 2017-09-28 |