MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-15 for UNK manufactured by Medline Industries Inc..
[141982623]
It was reported that the wheelchair could not be completely opened. As end-user sat on the partially unfolded wheelchair (the wheelchair was not completely opened), the end user's left index finger caught on the upholstery and side panel resulting in a finger avulsion. Reportedly, an unknown number of sutures was placed to stop the bleeding and an x-ray was performed, which showed no bone involvement related to the reported injury. On the same day the end user was discharged from the emergency department, the end user was sent to the plastic surgeon's clinic and she was told no repair could be done to the avulsed finger and this will heal by itself. The end user was reportedly prescribed with cephalexin (antibiotic), hydrocodone 5/325 (pain medication) and was told to apply mupirocin ointment with dressing changes twice daily. Reportedly, end user has followed up with the plastic surgeon four times since the initial visit for continued monitoring of the wound. Due to the reported injury and required medical intervention, this medwatch is being filed. The sample is not available to be returned for evaluation. The end-user is unable and/or unwilling to provide the catalogue number of the wheelchair involved in this event. A root cause could not be determined at this time. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[141982624]
It was reported that as end-user was sitting on the partially unfolded wheelchair, her left index finger caught on the upholstery and side panel resulting in a finger avulsion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2019-00052 |
| MDR Report Key | 8515759 |
| Report Source | CONSUMER |
| Date Received | 2019-04-15 |
| Date of Report | 2019-04-15 |
| Date of Event | 2019-03-12 |
| Date Mfgr Received | 2019-03-20 |
| Date Added to Maude | 2019-04-15 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | BERMON PUNZALAN |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | UNKNOWN WHEELCHAIR |
| Product Code | IOR |
| Date Received | 2019-04-15 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-15 |