MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2015-01-05 for VISI-FLOW IRRIGATION STARTER SET 1 3/4" 022800 manufactured by Convatec, Inc.
[5127031]
It was reported there were black, "mold-like" spots along the irrigation tube, which appeared like mold spots.
Patient Sequence No: 1, Text Type: D, B5
[12632308]
Based on the available info, this event is deemed to be a reportable malfunction. No additional patient/event details have been provided to date. Should additional info become available a f/u report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1049092-2015-00002 |
| MDR Report Key | 4384413 |
| Report Source | 01,04 |
| Date Received | 2015-01-05 |
| Date of Report | 2014-12-15 |
| Date of Event | 2014-12-14 |
| Date Mfgr Received | 2014-12-15 |
| Date Added to Maude | 2015-01-14 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW WALENCIAK, DIR |
| Manufacturer Street | 211 AMERICAN AVE. |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 9083779293 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VISI-FLOW IRRIGATION STARTER SET 1 3/4" |
| Generic Name | IRRIGATOR, OSTOMY |
| Product Code | EXD |
| Date Received | 2015-01-05 |
| Model Number | 022800 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC, INC |
| Manufacturer Address | 211 AMERICAN AVE. GREENSBORO NC 27409 US 27409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-05 |