MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2007-04-11 for CODMAN DISPOSABLE VEIN STRIPPER 63-4031 manufactured by Codman & Shurtleff, Inc..
[603313]
Affiliate reported that a brilliance artificer was used to localize the piece of the probe that broke off in the channel near the thigh. An incision was made to retrieve the piece of the probe. In probing and stripping the saphenous vein. The probe broke off at the level of the insertion of the retainer where it inserts in the traction dome. As a result surgery was delayed.
Patient Sequence No: 1, Text Type: D, B5
[7921301]
Mfr has received the device for evaluation. Upon completion of the investigation, a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2007-00101 |
| MDR Report Key | 836699 |
| Report Source | 01,07 |
| Date Received | 2007-04-11 |
| Date of Event | 2006-11-23 |
| Date Mfgr Received | 2007-03-14 |
| Date Added to Maude | 2007-04-13 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW KING |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283106 |
| Manufacturer G1 | CODMAN & SHURTLEFF, INC. |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| 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 DISPOSABLE VEIN STRIPPER |
| Generic Name | STRIPPER VEIN, DISPOSABLE |
| Product Code | GAJ |
| Date Received | 2007-04-11 |
| Returned To Mfg | 2007-03-05 |
| Model Number | NA |
| Catalog Number | 63-4031 |
| Lot Number | MX457 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 823994 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-04-11 |