MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-05-17 for ABDUCTION PILLOW manufactured by Deroyal Industries.
[27010]
Pt underwent a left total hip procedure on 5/10/96. On the morning of 5/11/96, the pt was noted to have left foot drop. The physician indicated the pt probably has left peroneal nerve palsy secondary to a tight strap from the abduction pillow around the pt's left calf. He also stated that the pt is susceptible due to pre-op back problems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 33962 |
| MDR Report Key | 33962 |
| Date Received | 1996-05-17 |
| Date of Report | 1996-05-14 |
| Date of Event | 1996-05-11 |
| Date Facility Aware | 1996-05-13 |
| Report Date | 1996-05-14 |
| Date Added to Maude | 1996-07-10 |
| 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 |
| 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 | ABDUCTION PILLOW |
| Generic Name | ABDUCTION PILLOW WITH CONCAVE PILLOW |
| Product Code | IOZ |
| Date Received | 1996-05-17 |
| Lot Number | UNKNOWN |
| ID Number | M60-0250M |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 35303 |
| Manufacturer | DEROYAL INDUSTRIES |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-05-17 |