MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-06 for MALE EXTERNAL CATHETER LATEX MEDIUM (25MM). 64002 5 manufactured by Unomedical S.r.o..
[30857721]
Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4). Convatec is submitting this report pursuant to the provisions of 21cfr part 803. Blank fields on this form indicate the information is unknown, unavailable or unchanged. Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).
Patient Sequence No: 1, Text Type: N, H10
[30857722]
It was reported that the product has micro-holes. Leaks urine through the hole.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005778470-2015-31282 |
| MDR Report Key | 5207983 |
| Date Received | 2015-11-06 |
| Date of Report | 2014-02-27 |
| Date of Event | 2014-04-16 |
| Date Mfgr Received | 2014-02-27 |
| Date Added to Maude | 2015-11-06 |
| 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 | JEANETTE JOHNSON |
| Manufacturer Street | 211 AMERICAN AVE |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3362973009 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MALE EXTERNAL CATHETER LATEX MEDIUM (25MM). |
| Generic Name | DEVICE, INCONTINENCE, UROSHEATH TYPE, STERILE |
| Product Code | EXJ |
| Date Received | 2015-11-06 |
| Model Number | 64002 5 |
| Lot Number | CR220503 |
| Device Expiration Date | 2017-05-01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-11-06 |