D
Patient 1
INCIDENT OCCURRED OUTSIDE THE USA: DURING VEIN STRIPPING PROCEDURE, A PLASTIC PROBE TIP BROKE OFF AND STUCK INSIDE AND REMAINED IN THE PATIENT. REVISION SURGERY WAS PERFORMED TO REMOVE THE TIP.
MAUDE MDR 846047
- MDR report key
- 846047
- Report number
- 2916714-2007-00019
- Event key
- 0
- Event type
- 3
- Date of event
- 2007-02-09
- Date received
- 2007-05-07
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- DEE SCHLUETER
- Address
- 3773 CORPORATE PKWY. CENTER VALLEY PA 18034 US
- Phone
- 800-800-8002
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NABATOFF VEIN STRIPPER SET | STRIPPER, VEIN, REUSABLE | AESCULAP, INC. | GAI | NA | FB030R | UNK | N | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2007-05-07 | 0 |
Event Narratives#
N
Patient 1
THE INCIDENT OCCURRED OUTSIDE THE USA. THE SAMPLE WAS NOT RETURNED. AN EVALUATION OF ALL AVAILABLE INFORMATION WAS PERFORMED BY THE MANUFACTURER, AESCULAP AG. THE INCIDENT WAS ATTRIBUTED TO POSSIBLE EMBRITTLEMENT OF THE SYNTHETIC MATERIAL AFTER STERILIZATION. PRODUCT WAS MANUFACTURED IN 1998. IN MARCH 2004 A MODIFICATION OF PRODUCT TOOK PLACE.