MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-12-26 for MARK II, URIXSON, HIP POSITIONER * 4050 manufactured by Innomed, Inc..
[36493]
When removing the hip positioner after the case it ws noted that the posterior post was bent and was protruding into the pt r buttock. Tissue was reddened with white indentation but no breakdown noted at that time. Area was 4" x 4".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 58898 |
| MDR Report Key | 58898 |
| Date Received | 1996-12-26 |
| Date of Report | 1996-07-11 |
| Date of Event | 1996-05-16 |
| Date Facility Aware | 1996-05-16 |
| Report Date | 1996-06-03 |
| Date Reported to Mfgr | 1996-07-11 |
| Date Added to Maude | 1996-12-31 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | MARK II, URIXSON, HIP POSITIONER |
| Generic Name | HIP POSITIONER |
| Product Code | KIL |
| Date Received | 1996-12-26 |
| Model Number | * |
| Catalog Number | 4050 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 59333 |
| Manufacturer | INNOMED, INC. |
| Manufacturer Address | 4700 L HWY 80 E SOVONA GA 31410 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-12-26 |