MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2014-08-18 for STOMAHESIVE PASTE 183910 manufactured by Convatec, A Division Of E.r. Squibb & Sons L.l.c..
[4866372]
The pt reportedly neglected to remove the plastic from wafer prior to application. The pt realized the mistake after the paste and wafer were applied and immediately tried to remove product. The pt had difficulty removing the paste and, as a result, has denudement to the skin from 1/2" surrounding stoma outward. No further info was provided.
Patient Sequence No: 1, Text Type: D, B5
[12332150]
Analysis is taken from a trending report of evaluations or adverse events finalized 05/2011. 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 issued april 16, 2014. Device (s) listed in this report is (are) used for treatment, not 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 | 1049092-2014-10480 |
| MDR Report Key | 4059298 |
| Report Source | 04,07 |
| Date Received | 2014-08-18 |
| Date of Report | 2012-02-09 |
| Date Mfgr Received | 2012-02-09 |
| Date Added to Maude | 2014-09-08 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW WALENCIAK, 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 | STOMAHESIVE PASTE |
| Generic Name | CEMENT, STOMAL APPLIANCE, OSTOMY |
| Product Code | EZR |
| Date Received | 2014-08-18 |
| Model Number | 183910 |
| 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, A DIVISION OF E.R. SQUIBB & SONS L.L.C. |
| Manufacturer Address | 211 AMERICAN AVE. GREENSBORO NC 27409 US 27409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-08-18 |