MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2015-01-20 for VISI-FLOW IRRINGATION STARTER SET 1 3/4" 45M 022800 manufactured by Convatec, Inc..
[5387465]
The end user reported black residue in the irrigator tube. It was thought to be mold.
Patient Sequence No: 1, Text Type: D, B5
[12759796]
Based on the available info, this event is deemed a reportable malfunction. No add'l pt/event details have been provided to date. Should add'l info become available, a f/u report will be submitted. Reported to fda on (b)(4) 2015.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1049092-2015-00031 |
| MDR Report Key | 4441836 |
| Report Source | 01,04 |
| Date Received | 2015-01-20 |
| Date of Report | 2015-01-08 |
| Date of Event | 2015-01-07 |
| Date Mfgr Received | 2015-01-08 |
| Date Added to Maude | 2015-02-10 |
| 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 WELANCIAK, ASSOC, 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 IRRINGATION STARTER SET 1 3/4" 45M |
| Generic Name | IRRIGATOR, OSTOMY |
| Product Code | EXD |
| Date Received | 2015-01-20 |
| 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 | 2015-01-20 |