MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2014-10-08 for CRUTCH 8153-A manufactured by Jan Mao.
[4910442]
Dealer stated that the end user was walking with her 813-a elbow crutch when the rivet that connects the cuff to the cane snapped off. Dealer advised end user fell inside of her home, in the hallway, against the wall, then down to the ground, causing her right elbow and arm to be in pain. End user did not seek any medical attention at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1531186-2014-04789 |
| MDR Report Key | 4152038 |
| Report Source | * |
| Date Received | 2014-10-08 |
| Date of Report | 2014-10-07 |
| Date of Event | 2014-10-07 |
| Date Facility Aware | 2014-10-07 |
| Report Date | 2014-10-08 |
| Date Reported to FDA | 2014-10-08 |
| Date Reported to Mfgr | 2014-10-08 |
| Date Added to Maude | 2014-10-08 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | 2014-10-08 |
| Model Number | 8153-A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 44 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JAN MAO |
| Manufacturer Address | HUIZHOU CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-10-08 |