MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2006-11-01 for CODMAN DISPOS VEIN STRIP 63-4031 manufactured by Codman & Shurtleff, Inc..
[17038252]
Affiliate reports that the veinstripper has broken in the distal part. A part of the device has been lost in the patient. X-ray needed. Risk of new surgery. Additional info from affiliate explained that a new surgery may be required in the future and that the remainder of the device was discarded.
Patient Sequence No: 1, Text Type: D, B5
[17205816]
It was communicated by the affiliate that the remainder of the device has been discarded. Without the device codman is unable to conduct a proper investigation. Since a lot number has been provided a review of the device history records will be performed. We anticipate that the review will confirm that the device conformed to all testing and manufacturing specifications. If anything other wise is noted a follow-up report will be filed. In addition, if and when a second surgery is performed to retrieve the product and if it returned for evaluation this complaint will be re-opened. Trends will be monitored for this and similar complaints. At the present time this complaint is considered to be closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2006-00295 |
| MDR Report Key | 775175 |
| Report Source | 01,07 |
| Date Received | 2006-11-01 |
| Date of Event | 2006-09-26 |
| Date Mfgr Received | 2006-10-04 |
| Date Added to Maude | 2006-11-02 |
| 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 DISPOS VEIN STRIP |
| Generic Name | STRIPPER, VEIN, DISPOSABLE |
| Product Code | GAJ |
| Date Received | 2006-11-01 |
| Model Number | NA |
| Catalog Number | 63-4031 |
| Lot Number | KX552 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 762955 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US |
| Baseline Brand Name | CODMAN DISPOSABLE VEIN STRIPPER |
| Baseline Generic Name | STRIPPER, VEIN, DISPOSABLE |
| Baseline Model No | NA |
| Baseline Catalog No | 63-4031 |
| Baseline ID | NA |
| Baseline Device Family | CODMAN DISPOSABLE VEIN STRIPPER |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-11-01 |