MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-05-05 for POSITION RECLINER 99-0012-7 manufactured by Lumex.
[19890272]
Facility alleges pt injured his head against the wall after chair gave up and tilted backwards. Pt was lying in the t-berg position before incident. Pt reported to be stable. (no bleeding).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243621-1995-00436 |
| MDR Report Key | 22289 |
| Date Received | 1995-05-05 |
| Date of Report | 1995-05-01 |
| Date of Event | 1995-04-15 |
| Date Facility Aware | 1995-04-25 |
| Report Date | 1995-05-01 |
| Date Reported to FDA | 1995-05-01 |
| Date Reported to Mfgr | 1995-05-01 |
| Date Added to Maude | 1995-06-08 |
| 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 | POSITION RECLINER |
| Generic Name | POSITION RECLINER |
| Product Code | FIA |
| Date Received | 1995-05-05 |
| Catalog Number | 99-0012-7 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 22406 |
| Manufacturer | LUMEX |
| Manufacturer Address | BAYSHORE NY 11706 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-05-05 |