FDA Adverse Event
Injury
Summary report: N
EAKIN COHESIVE SEAL SMALL
MDR report key: 5290233
·
Received December 11, 2015
Report
- Report Number
- 9681410-2015-40105
- Event Type
- Injury
- Date Received
- December 11, 2015
- Report Date
- November 6, 2015
- Manufacturer
- T.G. EAKIN LTD.
- Product Code
- EXE
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, 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. 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 THAT AREA UNDER SEAL IS RED AND WEEPING AND SOMETIMES HE NOTICES A LITTLE BLOOD. HE STATES THIS HAS BEEN HAPPENING OVER THE PAST YEAR. WHEN ASKED IF HE HAD EVER LEFT THE SEAL OFF HE STATED I NEVER THOUGHT OF THAT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 820428 | EAKIN COHESIVE SEAL SMALL | PROTECTOR, OSTOMY | EXE | T.G. EAKIN LTD. | 839002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | ALBUTEROL, NAPROXEN DAILY, UNSPECIFIED MEDICATION |