MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-09-11 for CODMAN DISPOS VEIN STRIP 63-4031 manufactured by Codman & Shurtleff, Inc..
[714270]
Customer reported that (procedure was stripping greater saphenous vein). The stripper head appeared to have pulled the tip of the stripper wire off and the wire came out. There was no apparent injury or delayed noted.
Patient Sequence No: 1, Text Type: D, B5
[7862867]
It has been communicated that the device is not available for eval. 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 mfg records have been reviewed and they revealed that the device conformed to all mfg and quality testing/inspection specifications prior to being released to stock. If at some point the device is returned for eval this complaint will be re-opened and investigated. Based on this eval, no further action is required. Trends will be monitored for this and similar complaints. At the present time this complaint is closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2007-00241 |
| MDR Report Key | 920297 |
| Report Source | 05,06 |
| Date Received | 2007-09-11 |
| Date of Event | 2007-07-26 |
| Date Mfgr Received | 2007-08-13 |
| Date Added to Maude | 2007-10-01 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW KING |
| Manufacturer Street | 325 PARAMOUNT DR. |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283106 |
| Manufacturer G1 | CODMAN & SHURTLEFF, INC. |
| Manufacturer Street | 325 PARAMOUNT DR. |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CODMAN DISPOS VEIN STRIP |
| Generic Name | STRIPPER, VEIN, DISPOSABLE |
| Product Code | GAJ |
| Date Received | 2007-09-11 |
| Model Number | NA |
| Catalog Number | 63-4031 |
| Lot Number | JY639 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 878718 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-09-11 |