MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1999-01-29 for MEDICHAIR 020-0205 NA manufactured by Sunrise Medical, Inc. Hoyer Div..
[16397590]
It was reported that a male pt was in the chair. The head of the chair was positioned approx less than ninety degree angle. The nurse was turned away and the pt slid down the chair, causing the chair to tip forward. The pt fell forward and hit his head on the floor. He required sutures to his forehead.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182598-1999-00001 |
| MDR Report Key | 207953 |
| Report Source | 06 |
| Date Received | 1999-01-29 |
| Date of Event | 1998-12-26 |
| Date Mfgr Received | 1998-12-30 |
| Date Added to Maude | 1999-02-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDICHAIR |
| Generic Name | CHAIR |
| Product Code | FZK |
| Date Received | 1999-01-29 |
| Model Number | 020-0205 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 201838 |
| Manufacturer | SUNRISE MEDICAL, INC. HOYER DIV. |
| Manufacturer Address | 2815 OREGON ST. OSHKOSH WI 54901 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-01-29 |