MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-03-05 for FOREARM CRUTCH G05160 manufactured by Medline Industries, Inc..
[16633067]
It was reported that the cuff on the crutch broke, the end user fell and tore ligaments in his left knee.
Patient Sequence No: 1, Text Type: D, B5
[16694337]
It was reported that the cuff on the forearm crutch broke and the end user fell. He tore ligaments in his left knee which required a knee brace. He was also prescribed vicodin, valium and physical therapy. We received photos but no sample for evaluation. The photos showed signs of extensive use. One crutch was missing the mount bracket and cuff. No manufacturing defects were observed in the photos. A root cause has not been determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2015-00019 |
| MDR Report Key | 4585168 |
| Report Source | 04 |
| Date Received | 2015-03-05 |
| Date of Report | 2015-03-02 |
| Date of Event | 2014-11-01 |
| Date Mfgr Received | 2015-02-10 |
| Date Added to Maude | 2015-03-11 |
| 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 | 3 |
| Manufacturer Contact | JULIE FINLEY |
| Manufacturer Street | ONE MEDLINE PLACE |
| 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 | FOREARM CRUTCH |
| Product Code | IPR |
| Date Received | 2015-03-05 |
| Catalog Number | G05160 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Other; 2. Required No Informationntervention | 2015-03-05 |