MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-06 for CAREX TMF0362277 manufactured by Tops Medical Articles Industries.
[101652101]
The end-user used the product and it burned her right knee, necessitating emergency treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012316249-2018-00008 |
| MDR Report Key | 7318080 |
| Date Received | 2018-03-06 |
| Date of Report | 2018-03-06 |
| Date of Event | 2016-07-02 |
| Date Facility Aware | 2017-10-26 |
| Report Date | 2018-03-06 |
| Date Reported to FDA | 2018-03-06 |
| Date Reported to Mfgr | 2018-03-06 |
| Date Added to Maude | 2018-03-06 |
| 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 |
| Reporter Occupation | ATTORNEY |
| 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 | CAREX |
| Generic Name | RITE AID INSTANT COLD THERAPY WRAP |
| Product Code | IME |
| Date Received | 2018-03-06 |
| Model Number | TMF0362277 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TOPS MEDICAL ARTICLES INDUSTRIES |
| Manufacturer Address | SOUTH HEZHU TWON QIDONG CITY JIANGSU PROVINCE, 226215 CH 226215 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2018-03-06 |