MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2006-10-18 for CODMAN DISPOSABLE VEIN STRIPPER 63-4031 manufactured by Codman & Shurtleff, Inc..
[21346482]
It was reported that the device has been discarded. Without the device, codman is unable to conduct a proper investigation. Since a lot number has been provided, codman has reviewed the device history records. It was noted that the review of the device history records confirmed that the device conformed to all testing/manufacturing specifications when released to stock. If at some point, the device is sent in for evaluation, the complaint will be reopened. Based on the results of this investigation, no further action is required. 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
[21583095]
Affiliate reported that during a vein stripping procedure, the tip of the instrument broke off. An x-ray and echogram was performed to try to locate the broken tip, which was unsuccessful. A lot number has been provided, however, the customer cannot confirm that the complaint device corresponds to the lot number provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2006-00287 |
| MDR Report Key | 770970 |
| Report Source | 01,07 |
| Date Received | 2006-10-18 |
| Date of Event | 2006-09-28 |
| Date Mfgr Received | 2006-09-28 |
| Device Manufacturer Date | 2005-12-01 |
| Date Added to Maude | 2006-10-20 |
| 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 | 2006-10-18 |
| Model Number | NA |
| Catalog Number | 63-4031 |
| Lot Number | MX464 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 758770 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | 325 PARAMOUNT DRIVE 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 | 2006-10-18 |