MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2013-11-07 for STOMAHESIVE PASTE (1TUBEX56.7G) US 183910 manufactured by Convatec Inc..
[4019415]
An end user called in and stated he believes he's experiencing contact dermatitis to his peristomal skin in the area where the stomahesive paste had been applied. The end user stated it began about nine (9) months ago and went on to state the area has not gotten better or worse.
Patient Sequence No: 1, Text Type: D, B5
[11412972]
Based on the available info this event is deemed a serious injury. The end user stated he saw an allergist who preformed a skin patch test. The end user also requested a list of ingredients in the product and the material safety data sheet (mds) was provided. No additional pt/event details have been provided to date. Should additional info become available a follow-up report will be submitted. A return sample for evaluation is not expected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1049092-2013-00190 |
| MDR Report Key | 3476734 |
| Report Source | 04,07 |
| Date Received | 2013-11-07 |
| Date of Report | 2013-10-09 |
| Date of Event | 2013-02-27 |
| Date Mfgr Received | 2013-10-09 |
| Date Added to Maude | 2013-11-20 |
| 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. DIRECTOR |
| Manufacturer Street | 200 HEADQUARTERS PARK DRIVED |
| 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 (1TUBEX56.7G) US |
| Generic Name | PROTECTOR, OSTOMY |
| Product Code | EZR |
| Date Received | 2013-11-07 |
| Model Number | 183910 |
| Catalog Number | 183910 |
| 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 | 2013-11-07 |