FDA Adverse Event
Injury
Summary report: N
DURAHESIVE. WFR W/NATURA FLG
MDR report key: 5289983
·
Received December 11, 2015
Report
- Report Number
- 1049092-2015-40107
- Event Type
- Injury
- Date Received
- December 11, 2015
- Report Date
- November 6, 2015
- Manufacturer
- CONVATEC INC.
- Product Code
- EXE
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL (B)(4). CONVATEC IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21CFR PART 803. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT WILL BE FILED ON A SUPPLEMENTAL REPORT (MEDWATCH 3500A).
Description of Event or Problem · 1
END USER REPORTED DIFFICULTY REMOVING WAFER FROM SKIN AFTER 2 DAYS WEAR TIME. USES UNISOLVE AND PROTECTIVE BARRIER ALONG WITH SOAP AND OIL. TEAR TO SKIN IMMEDIATELY BELOW STOMA UNDER MASS. HAS HEALED. USE OF APPROPRIATE PRODUCT/ACCESSORY PRODUCT DISCUSSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 819879 | DURAHESIVE. WFR W/NATURA FLG | PROTECTOR, OSTOMY | EXE | CONVATEC INC. | 413161 | 2L08457 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |