MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-10-22 for WHEELCHAIR FOOTREST WCA806965HEMI manufactured by Medline Industries, Inc..
[4984923]
The end user cut her leg on the foot rest of the wheelchair. The laceration was repaired with sutures.
Patient Sequence No: 1, Text Type: D, B5
[12403340]
As the end user was rising from a sitting position, she suffered a 1. 5 inch long laceration on her left shin that was thought to be caused by the footrest. The laceration was repaired with sutures and the end user received a tetanus shot. The husband reported that time, the foot rests had been irregularities were found on the device. There were no missing parts or sharp edges. We could not confirm the device caused the incident and it is not clear what role it may have played. There were no distinguishing markings to identify it as a medline device. However, in an abundance of caution and due to the reported injury, this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00096 |
| MDR Report Key | 4209719 |
| Report Source | 04 |
| Date Received | 2014-10-22 |
| Date of Report | 2014-10-16 |
| Date of Event | 2014-09-24 |
| Date Mfgr Received | 2014-09-26 |
| Date Added to Maude | 2014-10-30 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JULIE FINLEY |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WHEELCHAIR FOOTREST |
| Product Code | IMM |
| Date Received | 2014-10-22 |
| Catalog Number | WCA806965HEMI |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-10-22 |