MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2015-05-12 for CRUTCH UNK manufactured by Unk.
[5775992]
Attorney sent an email to compass health regarding client who sustained injuries from defective crutch.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182780-2015-00003 |
| MDR Report Key | 4768312 |
| Report Source | 99 |
| Date Received | 2015-05-12 |
| Date of Report | 2015-05-08 |
| Date Facility Aware | 2015-04-14 |
| Report Date | 2015-05-08 |
| Date Reported to FDA | 2015-05-08 |
| Date Added to Maude | 2015-05-14 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRUTCH |
| Generic Name | CRUTCH |
| Product Code | IPR |
| Date Received | 2015-05-12 |
| Model Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-05-12 |