MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-08-18 for ICY HOT SMART RELIEF TENS BACK PAIN THERAPY manufactured by Chattem.
[83096241]
Initial information regarding this unsolicited case from united states was received on (b)(6)2017 from patient's wife. This case involves a male patient of unknown age, who ended up with 2 blisters on his back after receiving treatment with smart relief tens therapy (icy hot smart relief tens back pain therapy). Past drugs, medical history and concomitant medications were not reported. On (b)(6)2017, the patient started therapy with smart relief tens therapy at an unspecified frequency (lot/ batch number and expiry date: unknown) for hurting back. It was reported that patient used smart relief tens therapy for a bit that day ((b)(6)2017) and he ended up with 2 blisters on his back (onset date and latency: unknown). Action taken: unknown. Corrective treatment: not reported. Event outcome: unknown. Seriousness criteria: important medical event: a product technical complaint (ptc) was initiated with local ptc number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1022556-2017-00005 |
| MDR Report Key | 6805849 |
| Report Source | CONSUMER |
| Date Received | 2017-08-18 |
| Date of Report | 2017-08-04 |
| Date Mfgr Received | 2017-08-07 |
| Date Added to Maude | 2017-08-18 |
| 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 | 2017-08-18 |
| Lot Number | UNK |
| 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 | 2017-08-18 |