MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2011-01-26 for ESWL GAIT ATTACHMENT EQUIPMENT manufactured by United Therapies.
[1966635]
During lithotripsy procedure, the safety feature on the gait attachment for eswl equipment did not operate correctly. The equipment was being operated by the company rep. This was discussed with surgeon and anesthesiologist and the equipment was used without the gait attachment. Company rep took the equipment for testing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1982444 |
| MDR Report Key | 1982444 |
| Report Source | 99 |
| Date Received | 2011-01-26 |
| Date of Report | 2011-01-24 |
| Date of Event | 2011-01-11 |
| Date Facility Aware | 2011-01-11 |
| Report Date | 2011-01-24 |
| Date Reported to FDA | 2011-01-24 |
| Date Reported to Mfgr | 2011-01-24 |
| Date Added to Maude | 2011-02-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESWL GAIT ATTACHMENT EQUIPMENT |
| Generic Name | NONE |
| Product Code | NCV |
| Date Received | 2011-01-26 |
| Returned To Mfg | 2011-01-11 |
| Device Availability | R |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNITED THERAPIES |
| Manufacturer Address | 1111 EAST TOUHY AVE., STE 240 DES PLAINES IL 60018 US 60018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-01-26 |