MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-19 for MEDICHOICE ALUMINUM CRUTCHES 5'2 - 5'10 77708A manufactured by Owens & Minor Distribution, Inc..
[36236374]
Patient Sequence No: 1, Text Type: N, H10
[36236375]
Following discharge from the emergency room, the wing nut on one of the patient's crutches came loose on the hand grip, came out, causing the patient to fall onto her right side. Manufacturer response for crutches, medichoice aluminum crutches 5'2 - 5'10 (per site reporter): contacted field rep. Received return call from manufacturer requesting po # in order to provide ra for return. States that determination will be made whether or not an investigation of device will occur.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5376150 |
| MDR Report Key | 5376150 |
| Date Received | 2016-01-19 |
| Date of Report | 2016-01-14 |
| Date of Event | 2015-09-24 |
| Report Date | 2016-01-14 |
| Date Reported to FDA | 2016-01-14 |
| Date Reported to Mfgr | 2016-01-14 |
| Date Added to Maude | 2016-01-19 |
| 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 | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDICHOICE ALUMINUM CRUTCHES 5'2 - 5'10 |
| Generic Name | CRUTCHES |
| Product Code | IPR |
| Date Received | 2016-01-19 |
| Catalog Number | 77708A |
| Lot Number | CM1502 037576 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OWENS & MINOR DISTRIBUTION, INC. |
| Manufacturer Address | 9120 LOCKWOOD BLVD. MECHANICSVILLE VA 23116 US 23116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-01-19 |