MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-01 for STUMP SHRINKER manufactured by Wright & Filippis Inc.
[53725205]
Patient Sequence No: 1, Text Type: N, H10
[53725206]
Patient was status post knee amputation. A shrinker was applied by wright-fillippis rep and it was later determined that the shrinker might have been applied improperly or might have been too tight. The patient did experience harm to skin - deep tissue injury to right thigh, requiring additional monitoring by wound care and interventions for the patient's skin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5920457 |
| MDR Report Key | 5920457 |
| Date Received | 2016-09-01 |
| Date of Report | 2016-08-31 |
| Date of Event | 2016-08-25 |
| Report Date | 2016-08-31 |
| Date Reported to FDA | 2016-08-31 |
| Date Reported to Mfgr | 2016-08-31 |
| Date Added to Maude | 2016-09-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | STUMP SHRINKER |
| Generic Name | COVER, LIMB |
| Product Code | IPM |
| Date Received | 2016-09-01 |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHT & FILIPPIS INC |
| Manufacturer Address | 2845 CROOKS ROAD ROCHESTER HILLS MI 48309 US 48309 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-09-01 |