FDA Adverse Event
Injury
Summary report: N
TITAN TOUCH
MDR report key: 11703689
·
Received April 21, 2021
Report
- Report Number
- 2125050-2021-00408
- Event Type
- Injury
- Date Received
- April 21, 2021
- Report Date
- April 21, 2021
- Manufacturer
- COLOPLAST A/S
- Product Code
- JCW
- UDI-DI
- 05708932539135
- PMA / PMN Number
- K000006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT.
Description of Event or Problem · 1
ACCORDING TO AVAILABLE INFORMATION, THE PUMP INLET TUBING WAS FRACTURED AND REQUIRED REPLACEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 596113 | TITAN TOUCH | INFLATABLE PENILE PROSTHESIS | JCW | COLOPLAST A/S | ES28202400 | 05708932539135 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Hospitalization| R |