FDA Adverse Event
Malfunction
Summary report: N
ARIS
MDR report key: 1203537
·
Received October 17, 2008
Report
- Report Number
- 2125050-2008-00009
- Event Type
- Malfunction
- Date Received
- October 17, 2008
- Date of Event
- September 1, 2008
- Report Date
- September 17, 2008
- Manufacturer
- COLOPLAST MANUFACTURING US, LLC
- Product Code
- FTL
- PMA / PMN Number
- K050148
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE RETURN OF THE DEVICE HAS BEEN REQUESTED. IT IS UNK IF THE DEVICE IS STILL AVAILABLE. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, AN ADDENDUM TO THIS REPORT WILL BE FILED.
Description of Event or Problem · 1
AS REPORTED TO COLOPLAST, THE TAPE IS SLIGHTLY WIDER THAN USUAL I.E. 12MM INSTEAD OF 11MM. BEST ESTIMATE OF DATE OF THE EVENT IS 2008.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARIS | TRANS-OBTURATOR TAPE | FTL | COLOPLAST MANUFACTURING US, LLC | UR31011000 | A1010003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |