MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-14 for PROCARE 3 PANEL KNEE SPLINT 79-80020/ 79-80030 manufactured by Djo, Llc.
[57489309]
Patient Sequence No: 1, Text Type: N, H10
[57489310]
R knee immobilizer in place. R achilles area presents with deep maroon area, 4 cm x 3 cm. , skin remains intact. Area on immobilizer was padded. Now: aluminum stays removed from immobilizer and area padded and supported in a new and improved fashion. Risk and wound care feel this is a product defect as stays are not padded enough. Staff also involved as not checked often enough product needs extra padding near stays at any pressure points... Part of directions for use?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6030836 |
| MDR Report Key | 6030836 |
| Date Received | 2016-10-14 |
| Date of Report | 2016-09-28 |
| Date of Event | 2016-09-11 |
| Report Date | 2016-09-28 |
| Date Reported to FDA | 2016-09-28 |
| Date Reported to Mfgr | 2016-09-28 |
| Date Added to Maude | 2016-10-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | PROCARE 3 PANEL KNEE SPLINT |
| Generic Name | JOINT, KNEE, EXTERNAL BRACE |
| Product Code | ITM |
| Date Received | 2016-10-14 |
| Catalog Number | 79-80020/ 79-80030 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | 1430 DECISION ST VISTA CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2016-10-14 |