MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-06-15 for INVISIGRIP VEIN STRIPPER 1500-05 manufactured by .
[16834985]
The hospital reported that the nosepiece of the invisigrip vein stripper broke off in the pt. An extra incision was made to remove the nose piece. The pt has recovered.
Patient Sequence No: 1, Text Type: D, B5
[16964504]
In the initial report stated we will ask the physician for further info on the condition of the vessel or any other info he may be able to provide. The physician stated the vessel was not torturous. He has used this product many times without failure. The root cause of the tip detaching is unknown. The operators were made aware of this complaint and retraining was conducted as a preventive measure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220948-2007-00003 |
| MDR Report Key | 865422 |
| Report Source | 07 |
| Date Received | 2007-06-15 |
| Date of Report | 2007-05-16 |
| Date of Event | 2007-03-09 |
| Date Mfgr Received | 2007-03-09 |
| Date Added to Maude | 2008-02-28 |
| 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 Street | 63 2ND AVENUE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal | 01803 |
| Manufacturer Phone | 7812212266 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVISIGRIP VEIN STRIPPER |
| Generic Name | VEIN STRIPPER |
| Product Code | GAJ |
| Date Received | 2007-06-15 |
| Returned To Mfg | 2007-03-12 |
| Model Number | 1500-05 |
| Catalog Number | 1500-05 |
| Lot Number | IVS1037 |
| Device Expiration Date | 2011-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 961274 |
| Manufacturer Address | 63 2ND AVENUE BURLINGTON MA 01803 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-06-15 |