MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-12-31 for GENTLE CATH 421911 manufactured by Unomedical S.r.o..
| Report Number | 3005778470-2019-00196 |
| MDR Report Key | 9535850 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2019-12-31 |
| Date of Event | 2019-12-01 |
| Date Mfgr Received | 2020-01-30 |
| Date Added to Maude | 2019-12-31 |
| 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 | MS. JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3365424681 |
| Manufacturer G1 | UNOMEDICAL S.R.O. |
| Manufacturer Street | PRIEMYSELNY PARK 3, |
| Manufacturer City | MICHALOVCE 07101 |
| Manufacturer Country | LO |
| Manufacturer Postal Code | 07101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GENTLE CATH |
| Generic Name | CATHETER, URETHRAL |
| Product Code | GBM |
| Date Received | 2019-12-31 |
| Model Number | 421911 |
| Lot Number | 8G00725 |
| Device Expiration Date | 2019-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNOMEDICAL S.R.O. |
| Manufacturer Address | PRIEMYSELNY PARK 3, MICHALOVCE 07101 LO 07101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-12-31 |