FDA Adverse Event
Other
Summary report: N
HEMOLOK LIGATING CLIP
MDR report key: 1060931
·
Received June 12, 2008
Report
- Report Number
- 3003898360-2008-00036
- Event Type
- Other
- Date Received
- June 12, 2008
- Report Date
- May 27, 2008
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- GDO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
UNABLE TO DETERMINE AT THIS TIME DUE TO LACK OF CATALOG #. AT TIME OF THIS REPORT, THERE IS NO INFO TO IDENTIFY CATALOG # OR LOT #. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW UP REPORT WILL BE SENT IF ANY ADDITIONAL INFO IS RECEIVED.
Description of Event or Problem · 1
INCIDENT REPORTED AS: THE SALES REP RECEIVED A CALL FROM A DR WHO SAID PT HAD HEMOCLIPS PLACED IN HER DURING A GYN SURGICAL PROCEDURE IN 1999. THE PT DEVELOPED A NEUROLOGICAL DISEASE CALLED STIFF MAN'S SYNDROME USUALLY CAUSED BY EXPOSURE TO COBALT OR NICKLE. SHE IS ASKING THE DR TO REMOVE CLIPS. THEY DO NOT KNOW CATALOG # OR LOT # INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMOLOK LIGATING CLIP | LIGATING CLIPS | GDO | TELEFLEX MEDICAL | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |