MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-20 for CAREX TMF32411102 manufactured by Tops Medical Articles Industries.
[92529080]
The user fell at work, and sprained her knee - she had been going to physical therapy, and when she is done, they put an ice pack on her. She was home, and her knee was sore, and she had an ice pack that she bought her son last year. She put it on, and it hurt, but she kept it on for 15 minutes. Her knee after that time was very sore, swollen, and very red. She put a bandage on it and went back to work. Her boss saw her, and he called her in to look at her knee, and he told her she needed to go to urgent care. The doctor there told her she had second degree frostbite, and they gave her a cream to put on.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012316249-2017-00133 |
| MDR Report Key | 7045823 |
| Date Received | 2017-11-20 |
| Date of Report | 2017-11-20 |
| Date Facility Aware | 2017-10-30 |
| Report Date | 2017-11-20 |
| Date Reported to FDA | 2017-11-20 |
| Date Reported to Mfgr | 2017-11-20 |
| Date Added to Maude | 2017-11-20 |
| 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 | 3 |
| Brand Name | CAREX |
| Generic Name | COLD PACK |
| Product Code | IME |
| Date Received | 2017-11-20 |
| Model Number | TMF32411102 |
| 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; 2. Required No Informationntervention | 2017-11-20 |