FDA Adverse Event
Injury
Summary report: N
HS CATHETER, 5F
MDR report key: 4692493
·
Received April 9, 2015
Report
- Report Number
- MW5042080
- Event Type
- Injury
- Date Received
- April 9, 2015
- Date of Event
- April 2, 2015
- Report Date
- April 9, 2015
- Manufacturer
- CATHETER RESEARCH, INC. DBA THOMAS MEDICAL INC
- Product Code
- DRA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IL, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
PLASTIC SHEATH REMAINED IN CERVIX AFTER REMOVAL OF CATHETER FOLLOWING PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 233425 | HS CATHETER, 5F | CATHETER | DRA | CATHETER RESEARCH, INC. DBA THOMAS MEDICAL INC | TMI1154 | J237E |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Required Intervention |