MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-19 for ETH10BB manufactured by Sterilmed, Inc..
[28673918]
It was reported that the device will not be returned for evaluation. The device history record could not be reviewed for discrepancies as the lot number was not reported. The device reported to be used in the procedure has a fixed tip with grasping non-smooth capabilities and is not interchangeable.
Patient Sequence No: 1, Text Type: N, H10
[28673919]
It was reported that there was a perforated urethra during the procedure. It was reported that the device used had the wrong tip, that it should have been smooth. A request for additional information was requested but it was reported that additional information will not be made available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2015-00049 |
| MDR Report Key | 5159701 |
| Date Received | 2015-10-19 |
| Date of Report | 2015-09-18 |
| Date of Event | 2015-09-18 |
| Date Added to Maude | 2015-10-19 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAY ANDERSON |
| Manufacturer Street | 5010 CHESHIRE PARKWAY STE 2 |
| Manufacturer City | PLYMOUTH MN 55446 |
| Manufacturer Country | US |
| Manufacturer Postal | 55446 |
| Manufacturer Phone | 7634888348 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | GDI |
| Date Received | 2015-10-19 |
| Model Number | ETH10BB |
| Catalog Number | ETH10BB |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 11400 73RD AVE N MAPLE GROVE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-10-19 |