FDA Adverse Event
Malfunction
Summary report: N
COLODRESS+ PCH CLD STD TAN 38MM
MDR report key: 5153708
·
Received October 15, 2015
Report
- Report Number
- 9618003-2015-30561
- Event Type
- Malfunction
- Date Received
- October 15, 2015
- Date of Event
- June 29, 2014
- Report Date
- February 27, 2014
- Manufacturer
- CONVATEC DOM. REPUBLIC
- Product Code
- EZQ
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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
THE MASS ADHERE VERY STRONGLY. IT'S VERY DIFFICULT TO REMOVE IT. PAIN ON REMOVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 684705 | COLODRESS+ PCH CLD STD TAN 38MM | POUCH, COLOSTOMY | EZQ | CONVATEC DOM. REPUBLIC | 403816 | 3H02780 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |