FDA Adverse Event
Malfunction
Summary report: N
TITAN
MDR report key: 10832785
·
Received November 12, 2020
Report
- Report Number
- 2125050-2020-01086
- Event Type
- Malfunction
- Date Received
- November 12, 2020
- Report Date
- November 12, 2020
- Manufacturer
- COLOPLAST A/S
- Product Code
- FHW
- PMA / PMN Number
- P000006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE LOT # WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE AND NO TRENDS WERE NOTED. 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 ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED LOT NUMBER: 0920382.
Description of Event or Problem · 1
ACCORDING TO THE AVAILABLE INFORMATION, THE PUMP COLLAPSES. THE DEVICE WAS REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1298060 | TITAN | INFLATABLE PENILE PROSTHESIS | FHW | COLOPLAST A/S | QS89161000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR |