MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-10 for BREEZY 18" INV DLW 228104 UNKNOWN manufactured by Sunrise-medical Quickiee.
[13240]
Sustained 2 1/2 inch long by 1/2 inch deep laceration to right lower leg, inner aspect above ankle. Believed to have been caused by wheelchair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 25471 |
| MDR Report Key | 25471 |
| Date Received | 1995-01-10 |
| Date of Report | 1994-09-08 |
| Date of Event | 1994-09-08 |
| Date Facility Aware | 1994-09-08 |
| Report Date | 1994-09-09 |
| Date Added to Maude | 1995-09-14 |
| 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 | BREEZY 18" |
| Generic Name | WHEELCHAIR |
| Product Code | KID |
| Date Received | 1995-01-10 |
| Model Number | INV DLW 228104 |
| Catalog Number | UNKNOWN |
| Lot Number | NI |
| ID Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 25969 |
| Manufacturer | SUNRISE-MEDICAL QUICKIEE |
| Manufacturer Address | 2842 BUSINESS PARK AVE. FRESNO CA 93727 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-01-10 |