MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-03-14 for TEMPTEK KNEE BLANKET 5030 manufactured by Temptek, Inc..
[18447793]
Following surgery to repair a dislocated toe, the cold therapy pad was placed over the surgical site and controlled cold therapy was administered. After three days of continuous treatment, the pt returned for follow-up when it was noted that her toe was discolored and her foot was cold to the touch. Two weeks later, the pt required an amputation of the operated toe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2242816-1996-00023 |
| MDR Report Key | 32479 |
| Date Received | 1996-03-14 |
| Date of Report | 1996-03-14 |
| Date of Event | 1996-03-07 |
| Date Facility Aware | 1996-03-07 |
| Report Date | 1996-03-14 |
| Date Reported to FDA | 1996-03-14 |
| Date Reported to Mfgr | 1996-03-14 |
| Date Added to Maude | 1996-05-06 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEMPTEK KNEE BLANKET |
| Generic Name | COLD THERAPY PAD |
| Product Code | IMF |
| Date Received | 1996-03-14 |
| Model Number | 5030 |
| Catalog Number | 5030 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 33759 |
| Manufacturer | TEMPTEK, INC. |
| Manufacturer Address | 1454 HALSEY WAY CARROLLTON TX 75007 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-03-14 |