MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-02-26 for CRUTCH MDS80541 manufactured by Medline Industries, Inc..
[18932642]
The end user fell navigating down a set of stairs while using the crutches.
Patient Sequence No: 1, Text Type: D, B5
[19065756]
It was reported that while walking down a set of stairs the crutch bent and the end user fell. He hit his head on a truck parked at the bottom of the stairs and lost consciousness for a few seconds. He apparently sought medical treatment two days later. No serious injury was diagnosed and no medical treatment was provided. Minimal details regarding the incident were provided. The sample was returned and evaluated. The shaft of one crutch was bent at the location of the height adjustment just above the handgrip. No manufacturing defect was identified. A root cause has not been determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2015-00015 |
| MDR Report Key | 4564886 |
| Report Source | 08 |
| Date Received | 2015-02-26 |
| Date of Report | 2015-02-23 |
| Date of Event | 2015-01-01 |
| Date Mfgr Received | 2015-01-29 |
| Device Manufacturer Date | 2013-01-01 |
| Date Added to Maude | 2015-03-04 |
| 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 | 0 |
| 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 | CRUTCH |
| Product Code | IPR |
| Date Received | 2015-02-26 |
| Catalog Number | MDS80541 |
| Lot Number | N130108508 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| 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 | 2015-02-26 |