FDA Adverse Event
Injury
Summary report: N
S4S/SUR-FIT NATURA 2 PC - 2 PC STOMAHESIVE (SH) WAFER W/ FLEXIBLE COLLAR
MDR report key: 4122197
·
Received September 17, 2014
Report
- Report Number
- 1049092-2014-11495
- Event Type
- Injury
- Date Received
- September 17, 2014
- Report Date
- April 1, 2013
- Manufacturer
- CONVATEC, INC.
- Product Code
- EXE
- PMA / PMN Number
- K830945
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS IS TAKEN FROM A TRENDING REPORT OF EVALUATION OR ADVERSE EVENTS FINALIZED MAY 2011. THE DATA PRESENTED IS FROM THREE DIFFERENT PRODUCT APPLICATIONS. THE REPORT STATES THAT THERE ARE NO SIGNIFICANT TRENDS.
Description of Event or Problem · 1
REPORT RECEIVED INDICATED THE PT EXPERIENCED RASH AND ITCHINESS UNDER WAFER MASS AND TAPE BORDER FOR TWO MONTHS. REPORT ALSO INDICATED THAT THE RASH WAS WEEPY AND WET. INTERMITTENT APPEARANCE OVER FIVE YEAR USE OF DEVICE. PT OUTCOME WAS NOT NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 575748 | S4S/SUR-FIT NATURA 2 PC - 2 PC STOMAHESIVE (SH) WAFER W/ FLEXIBLE COLLAR | PROTECTOR, OSTOMY | EXE | CONVATEC, INC. | 125264 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |