MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-09-28 for CODMAN DISPOSABLE VEIN STRIPPER 634031 manufactured by Codman And Shurtleff - Raynham.
[15537102]
Medwatch report explained that during vein stripping of left leg, the end nub of stripping device broke off inside the leg. The broken part was visible and was retrieved by an incision in the leg. All pieces of the device are accounted for and saved for quality.
Patient Sequence No: 1, Text Type: D, B5
[15866397]
It has been communicated that the device is not available for evaluation. Without the device it is not possible for codman to conduct a proper investigation. Since a lot number has been provided a review of the manufacturing records will be reviewed. We anticipate that the evaluation will reveal that the device conformed to specifications prior to release. If anything otherwise is found then a follow up report will be filed. If at some point the device does become available, this complaint will be re-opened, evaluated and a follow up report will be filed. Trends will be monitored for this and similar complaints. At the present time this complaint is considered closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2011-00374 |
| MDR Report Key | 2267980 |
| Report Source | 05 |
| Date Received | 2011-09-28 |
| Date of Event | 2011-06-20 |
| Report Date | 2011-09-02 |
| Date Reported to Mfgr | 2011-09-02 |
| Date Mfgr Received | 2011-09-02 |
| Date Added to Maude | 2011-09-28 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. MATTHEW KING |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CODMAN DISPOSABLE VEIN STRIPPER |
| Generic Name | STRIPPER, VEIN, DISPOSABLE |
| Product Code | GAJ |
| Date Received | 2011-09-28 |
| Catalog Number | 634031 |
| Lot Number | CA672 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN AND SHURTLEFF - RAYNHAM |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-09-28 |