MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-08-04 for FULL SIDE RAIL M2Q5000 manufactured by Am-fab Inc..
[17099]
There is a metal piece that is sandwiched where the bolt meets the tubular piece. This is part of the bedrail itself. The piece cracked at 45 degrees angle in a zagged fashion. Pt must have leaned against the side rail, broke the rail and fallen, sustaining a laceration above the eye. He was sent to the hosp where he required two stitched. No other pt problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1006611 |
| MDR Report Key | 24081 |
| Date Received | 1995-08-04 |
| Date of Report | 1995-07-21 |
| Date of Event | 1995-07-08 |
| Date Added to Maude | 1995-08-04 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FULL SIDE RAIL |
| Generic Name | FULL SIDE RAIL |
| Product Code | FNK |
| Date Received | 1995-08-04 |
| Catalog Number | M2Q5000 |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 24423 |
| Manufacturer | AM-FAB INC. |
| Manufacturer Address | 2525 MILLER RD KALAMAZOO MI 49001 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-08-04 |