MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-26 for UNK manufactured by Medline Industries, Inc..
[53301203]
It was reported that an end user fractured his ankle on (b)(6) 2015 and was provided a pair of crutches for ambulation. On (b)(6) 2015, while ambulating in his kitchen, the rubber tip of one of the crutches apparently wore through and he fell. It was reported that he suffered "a torn bicep and that the injury required surgery to reattach the ligament". We have no item number or lot number. There is no sample or photos to evaluate. We had not previously been made aware of this incident. No other details were provided to us. We have not confirmed the issue or identified a root cause. However, in an abundance of caution, due to the reported injury and need for surgical intervention, this medwatch is being filed. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[53301204]
The end user fell when the crutch tip wore through and suffered a torn bicep.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2016-00090 |
| MDR Report Key | 5908521 |
| Date Received | 2016-08-26 |
| Date of Report | 2016-08-26 |
| Date of Event | 2015-10-20 |
| Date Mfgr Received | 2016-08-09 |
| Date Added to Maude | 2016-08-26 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| 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 | 0 |
| Generic Name | CRUTCH |
| Product Code | INP |
| Date Received | 2016-08-26 |
| 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 | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2016-08-26 |