MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2014-10-14 for CRUTCH 8115-A manufactured by Healthplus.
[5090202]
Consumer states that a plastic sliding piece kept sliding to the bottom and made the crutches very wobbly and unsecured. Consumer attaches a screw to holding this sliding piece in place. No additional information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1531186-2014-04894 |
| MDR Report Key | 4168191 |
| Report Source | * |
| Date Received | 2014-10-14 |
| Date of Report | 2014-09-24 |
| Date of Event | 2014-08-26 |
| Date Facility Aware | 2014-09-24 |
| Report Date | 2014-10-13 |
| Date Reported to FDA | 2014-10-13 |
| Date Reported to Mfgr | 2014-10-13 |
| Date Added to Maude | 2014-10-14 |
| 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 | 0 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRUTCH |
| Generic Name | 890.3150 |
| Product Code | IPR |
| Date Received | 2014-10-14 |
| Model Number | 8115-A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEALTHPLUS |
| Manufacturer Address | HANDAN CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-10-14 |