MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-17 for THERMIPAQ TPF5201LP manufactured by Tops Medical Articles Industries.
[82981994]
The user had this device in the freezer for an hour, and put it over an elastic bandage that was wrapped around her ankle and top of foot. The user then fell asleep, woke up, and took the device off. The elastic bandage was wet in a couple of spots. The bandage was unwrapped, and the user immediately had large blisters. The user used an antibiotic lip treatment by accident, and when she wiped it off, her skin came off. The user went to the doctor's, and the doctor said she had second degree burns. The user was prescribed antibiotics, and put a cream and new dressing on her injuries every day, but also has an in-home care specialist come out that changes it twice a week.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012316249-2017-00100 |
| MDR Report Key | 6802397 |
| Date Received | 2017-08-17 |
| Date of Report | 2017-08-17 |
| Date of Event | 2017-07-07 |
| Date Facility Aware | 2017-07-21 |
| Report Date | 2017-08-17 |
| Date Reported to FDA | 2017-08-17 |
| Date Reported to Mfgr | 2017-08-17 |
| Date Added to Maude | 2017-08-17 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | 0 |
| Brand Name | THERMIPAQ |
| Generic Name | HOT/COLD PAIN RELIEF WRAP |
| Product Code | IME |
| Date Received | 2017-08-17 |
| Model Number | TPF5201LP |
| 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 HEZOU TOWN QIDONG CITY, 2226215 CH 2226215 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-08-17 |