MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-10-04 for BREEZY 18" INV DLW 228104 UNKNOWN manufactured by Sunrise Medical-quickiee.
[16277997]
Resident reached over the left side of her wheelchair legrest/foot pedal to pick something up off the floor. When she brought her arm back up to normal height, she discovered a laceration on her left forearm. It was found to be approximately 6 cm long with adipose tissue exposed. Upon evaluating possible cause it was found that her wheelchair legrest had a sharp plastic edge to it as well as an end to a nut/screw was found to be sharp. These were filed so not sharp. Exact cause of injury undetermined.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 16716 |
| MDR Report Key | 16716 |
| Date Received | 1994-10-04 |
| Date of Report | 1994-07-06 |
| Date of Event | 1994-06-27 |
| Date Facility Aware | 1994-06-28 |
| Report Date | 1994-07-06 |
| Date Reported to Mfgr | 1994-07-06 |
| Date Added to Maude | 1994-10-11 |
| 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 | IMM |
| Date Received | 1994-10-04 |
| 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 | 16649 |
| Manufacturer | SUNRISE MEDICAL-QUICKIEE |
| Manufacturer Address | 2842 BUSINESS PARK AVENUE FRESNO CA 93727 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-10-04 |