MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,07 report with the FDA on 2014-10-17 for VISI-FLOW-ACCESSORIES-IRRIGATION SET/PRODUCTS 650610 manufactured by Convatec, Inc..
[5095533]
It is reported by the retailer that the end user uses the device daily for the past 10 years. The end user reported that he replaces the device every half year. It is reported that in the last one year, the end user has had "several" episodes of general infection/fever which "felt like the flu. " it is reported that these several episodes were treated with antibiotics. The retailer does not know how many infections, however he will try to gain the info.
Patient Sequence No: 1, Text Type: D, B5
[12474295]
Based on the available info, this event is deemed a reportable serious injury. It is reported that the end user "was recommended to stop using the device. " it is reported that "at this moment the end user has no infections/fever and is not under medical treatment. " it is reported that the end user asked the retailer whether the infections might be the cause of the low product exchange rate twice a year. The lot number was unavailable because the end user stated the he did not have the retail box available. The actual date of event is unk, so the date used was the date convatec became aware. No add'l info has been provided to date. Should add'l info become available, a f/u report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1049092-2014-00531 |
| MDR Report Key | 4189075 |
| Report Source | 00,01,07 |
| Date Received | 2014-10-17 |
| Date of Report | 2014-09-26 |
| Date of Event | 2014-09-26 |
| Date Mfgr Received | 2014-09-26 |
| Date Added to Maude | 2014-10-22 |
| 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, 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-ACCESSORIES-IRRIGATION SET/PRODUCTS |
| Generic Name | OSTOMY IRRIGATOR |
| Product Code | EXD |
| Date Received | 2014-10-17 |
| Model Number | 650610 |
| Catalog Number | 650610 |
| Lot Number | UNK |
| 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 | 1. Required No Informationntervention | 2014-10-17 |