MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-07-09 for RED-DOT ALUMINUM CRUTCH G91-214-8 manufactured by Medline Industries.
[19985655]
The end user fell while walking with the crutches.
Patient Sequence No: 1, Text Type: D, B5
[20286273]
It was reported that while walking on a hardwood floor she fell when one of the red c clamps broke and the hand grip released. She is recovering from a left ankle reconstruction. She followed up with her surgeon and an x-ray revealed a small hairline fracture on her left fibula which she attributed to the fall. No medical treatment was provided. The sample was not returned for evaluation. Without a sample, a root cause has not been determined. Sample not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2015-00059 |
| MDR Report Key | 4902179 |
| Report Source | 04 |
| Date Received | 2015-07-09 |
| Date of Report | 2015-07-09 |
| Date of Event | 2015-06-11 |
| Date Mfgr Received | 2015-06-12 |
| Date Added to Maude | 2015-07-09 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | MS DIANE CHRISTENSEN |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8473644747 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RED-DOT ALUMINUM CRUTCH |
| Generic Name | CRUTCH |
| Product Code | IPR |
| Date Received | 2015-07-09 |
| Catalog Number | G91-214-8 |
| 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 |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-09 |