MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1998-12-16 for QUICKIE 2 WHEELCHAIR manufactured by Sunrise Medical Mpd.
[115367]
Rptr claims x-tube cracked at the center area while chair was in use. No injuries involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2082643-1998-01594 |
| MDR Report Key | 201905 |
| Report Source | 00 |
| Date Received | 1998-12-16 |
| Date of Report | 1998-12-16 |
| Date of Event | 1998-12-15 |
| Date Mfgr Received | 1998-12-15 |
| Date Added to Maude | 1998-12-17 |
| 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 | SERVICE PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUICKIE 2 WHEELCHAIR |
| Generic Name | WHEELCHAIR, MECHANICAL |
| Product Code | IRO |
| Date Received | 1998-12-16 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | P/N-672618 |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 196112 |
| Manufacturer | SUNRISE MEDICAL MPD |
| Manufacturer Address | 2842 BUSINESS PARK AVE. FRESNO CA 93727 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-12-16 |