MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-17 for THERAMED TMF0362277 manufactured by Tops Medical Articles Industries Nantong Inc.
[133471507]
Per the lawsuit: purchase date of cold wrap (b)(6) 2015 - said packaging did not provide any warnings concerning the use, application, and extent of time the device should remain in place and/or any harm which could arise from any allergy use of said product. While using the product (same day of purchase) in accordance with its intended use & pursuant to the written instructions set forth on the aforesaid label, was caused to suffer and sustain severe and permanent bodily injuries. The wrap caused severe and serious burns to the skin on the user's left leg, leaving her with severe, serious, disfiguring and permanent scarring. Item number of device involved with event could not be verified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012316249-2019-00002 |
| MDR Report Key | 8258840 |
| Date Received | 2019-01-17 |
| Date of Report | 2019-01-17 |
| Date of Event | 2015-12-13 |
| Date Facility Aware | 2019-01-02 |
| Report Date | 2019-03-22 |
| Date Reported to FDA | 2019-03-22 |
| Date Reported to Mfgr | 2019-03-22 |
| Date Added to Maude | 2019-01-17 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERAMED |
| Generic Name | RITE AID INSTANT COLD THERAPY WRAP |
| Product Code | IME |
| Date Received | 2019-01-17 |
| Model Number | TMF0362277 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TOPS MEDICAL ARTICLES INDUSTRIES NANTONG INC |
| Manufacturer Address | SOUTH HEZOUCAOJIA TOWN QIDONG CITY JIANGSU, 2226215 CH 2226215 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-17 |