MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-03-01 for MDSV80534 manufactured by Medline Industries Inc..
[101312571]
It was reported that the tip of a crutch ripped during use resulting in the customer falling, damaging his achilles tendon and requiring surgery. The customer reported that he initially had an achilles tendon injury on (b)(6) 2017 and was given the crutches at the hospital. On (b)(6) 2017 the customer reported that he was trying to stand up using the crutches and the crutch slipped out from under him resulting in the customer falling on the hardwood floor. Per the customer, after an mri evaluation he underwent surgery for the repair of a re-ruptured achilles tendon. The customer reported that he currently does not use any assistive device and he is walking independently. The sample was returned for evaluation. Upon investigation of the device, the sample was found to be in used condition. One crutch had the adjustable crutch leg protruding through the center of the bottom face of the tip. It is not known if the device caused or contributed to the fall; however the customer reported issue of a ripped crutch tip was confirmed. A root cause has not been determined. Due to the reported incident and subsequent need for surgical intervention, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[101312572]
It was reported that the tip of a crutch ripped during use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2018-00010 |
| MDR Report Key | 7307434 |
| Report Source | CONSUMER |
| Date Received | 2018-03-01 |
| Date of Report | 2018-03-01 |
| Date of Event | 2017-12-04 |
| Date Mfgr Received | 2018-02-08 |
| Date Added to Maude | 2018-03-01 |
| 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KAREN TRUTSCH |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 8476434960 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | CRUTCH,ALUMINUM,ADULT,TALL,LF,300LB |
| Product Code | IPR |
| Date Received | 2018-03-01 |
| Returned To Mfg | 2018-02-27 |
| Catalog Number | MDSV80534 |
| Lot Number | 74717060002 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-03-01 |