MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04,07 report with the FDA on 2013-10-28 for STOMAHESIVE PASTE (ITUBEX56, 7G) US 183910 manufactured by Convatec, Inc..
[3902477]
The end user stated he opened a new tube of stomahesive paste 3 days ago, and when he took his wafer off on the 3rd day, he noticed blistering on skin underneath the stomahesive paste.
Patient Sequence No: 1, Text Type: D, B5
[11378520]
Based on the available info this event is deemed a serious injury. The end user stated the stomahesive paste came from a home health agency when they were coming to his home and he is unsure if blistering is from paste or removing the wafer. No add'l pt/event details have been provided to date. Should add'l info become available, a f/u report will be submitted. A return sample for eval is not expected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1049092-2013-00149 |
| MDR Report Key | 3445055 |
| Report Source | 01,04,07 |
| Date Received | 2013-10-28 |
| Date of Report | 2013-09-30 |
| Date of Event | 2013-09-30 |
| Date Mfgr Received | 2013-09-30 |
| Device Manufacturer Date | 2012-08-01 |
| Date Added to Maude | 2013-11-05 |
| 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 | MARY SZARO, ASSOC., DIR. |
| Manufacturer Street | 200 HEADQUARTERS PARK DRIVE |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089042450 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STOMAHESIVE PASTE (ITUBEX56, 7G) US |
| Generic Name | PROTECTOR, OSTOMY |
| Product Code | EZR |
| Date Received | 2013-10-28 |
| Model Number | 183910 |
| Catalog Number | 183910 |
| Lot Number | 2H01997 |
| Device Expiration Date | 2017-08-20 |
| 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 | 2013-10-28 |