MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-06-25 for CAREX CRUTCHES manufactured by Carex Health Products.
[21494187]
I broke my ankle and had surgery to reconstruct it on (b)(6) 2014. My pharmacy supplied me with a pair of carex crutches on tuesday, (b)(6) 2014. The pharmacy is (b)(6). On (b)(6) 2014 i was using the crutches to go to the bathroom when one of them collapsed/bent as i was landing on it and i fell. I can send photos of the bowed crutch. I reported it to the pharmacy which delivered a different pair of crutches and reported it to the company via phone and email. This appears to be a dangerous defect. Dates of use: (b)(6) 2014.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5036923 |
| MDR Report Key | 3906233 |
| Date Received | 2014-06-25 |
| Date of Report | 2014-06-16 |
| Date of Event | 2014-05-23 |
| Date Added to Maude | 2014-07-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAREX CRUTCHES |
| Generic Name | CRUTCHES |
| Product Code | INP |
| Date Received | 2014-06-25 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREX HEALTH PRODUCTS |
| Manufacturer Address | 600 CORDWAINER DR. NORWELL MA 02061 US 02061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-25 |