MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2014-09-15 for STOMAHESIVE PASTE PROTECTIVE SKIN BARRIER 183910 UNK manufactured by Convatec Inc..
[4835172]
The patient reports an allergy to the product. The patient reported her skin became itchy and red after using the protective paste. The patient also indicated she uses multiple product brands and change the products frequently due to the location of the stoma. The patient sought medical attention from her local physician, however, details regarding the outcome of that appointment were not provided.
Patient Sequence No: 1, Text Type: D, B5
[12352978]
Analysis is taken from a trending report of evaluations or adverse events finalized may 2011. The data presented is from three different product applications. The report states that there are no significant trends. Convatec is submitting this report as a result of remediation activities related to the fda 483 issues april 16, 2014. Device (s) listed in this report is (are) used for treatment, no diagnosis. Any additional info received regarding this event after filing this report shall be filed on a supplemental mdr.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1049092-2014-11081 |
| MDR Report Key | 4101798 |
| Report Source | 04,07 |
| Date Received | 2014-09-15 |
| Date of Report | 2012-11-13 |
| Date of Event | 2012-11-01 |
| Date Mfgr Received | 2012-11-13 |
| Date Added to Maude | 2014-09-22 |
| 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, DIRECTOR |
| 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 | STOMAHESIVE PASTE PROTECTIVE SKIN BARRIER |
| Generic Name | CEMENT, STOMAL APPLIANCE, OSTOMY |
| Product Code | EZR |
| Date Received | 2014-09-15 |
| Model Number | 183910 |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID 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 | GREENSBORO NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-09-15 |