FDA Adverse Event
Malfunction
Summary report: N
GDC 10-SOFT SR STRETCH RESISTANT SYNERG DETECTION CIRCUIT
MDR report key: 387025
·
Received April 2, 2002
Report
- Report Number
- 6000078-2002-00032
- Event Type
- Malfunction
- Date Received
- April 2, 2002
- Date of Event
- February 25, 2002
- Report Date
- March 27, 2002
- Manufacturer
- TARGET THERAPEUTICS/A DIVISION OF BOSTON SCIENTIFIC CORPORATION
- Product Code
- HCG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO BSC/TARGET THAT GDC 10-SOFT SR STRETCH RESISTANT SYNERG DETECTION CIRCUIT DETACHED PREMATURELY. THE DEVICE WAS REMOVED SUCCESSFULLY. THE PATIENT'S CONDITION WAS NOT AFFECTED BY THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GDC 10-SOFT SR STRETCH RESISTANT SYNERG DETECTION CIRCUIT | DETACHABLE COIL | HCG | TARGET THERAPEUTICS/A DIVISION OF BOSTON SCIENTIFIC CORPORATION | * | 3918781 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |