MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2007-05-07 for NABATOFF VEIN STRIPPER SET FB030R manufactured by Aesculap, Inc..
[616606]
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.
Patient Sequence No: 1, Text Type: D, B5
[7874259]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2007-00019 |
| MDR Report Key | 846047 |
| Report Source | 01,07 |
| Date Received | 2007-05-07 |
| Date of Report | 2007-05-04 |
| Date of Event | 2007-02-09 |
| Date Mfgr Received | 2007-03-30 |
| Date Added to Maude | 2007-05-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DEE SCHLUETER |
| Manufacturer Street | 3773 CORPORATE PKWY. |
| Manufacturer City | CENTER VALLEY PA 18034 |
| Manufacturer Country | US |
| Manufacturer Postal | 18034 |
| Manufacturer Phone | 8002581946 |
| Manufacturer G1 | AESCULAP AG & CO. KG |
| Manufacturer Street | P.O. BOX 40 |
| Manufacturer City | TUTTLINGEN 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NABATOFF VEIN STRIPPER SET |
| Generic Name | STRIPPER, VEIN, REUSABLE |
| Product Code | GAI |
| Date Received | 2007-05-07 |
| Model Number | NA |
| Catalog Number | FB030R |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 833907 |
| Manufacturer | AESCULAP, INC. |
| Manufacturer Address | 3773 CORPORATE PKWY. CENTER VALLEY PA 18034 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-07 |