MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2007-01-16 for CODMAN DISPOS VEIN STRIP 83-4031 manufactured by Codman & Shurtleff, Inc..
[551585]
Affiliate reported that the distal part of the stripper which maintains the olive was detached from the cord. The surgeon had to make an incision to remove the olive and repeate the stripping.
Patient Sequence No: 1, Text Type: D, B5
[8056964]
It has been communicated by the affiliate that the device is not available for evaluation. However, since a lot number has been provided, a review of the device history records will be reviewed. We anticipate that the review will reveal that the device conformed to specifications prior to being released to stock. If anything otherwise is noted, a follow up report will be filed. 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 | 1226348-2007-00024 |
| MDR Report Key | 805693 |
| Report Source | 01,07 |
| Date Received | 2007-01-16 |
| Date of Event | 2006-12-06 |
| Date Mfgr Received | 2006-12-18 |
| Date Added to Maude | 2007-01-19 |
| 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 | 2007-01-16 |
| Model Number | NA |
| Catalog Number | 83-4031 |
| Lot Number | MX468 |
| 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 | 793202 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US |
| Baseline Brand Name | CODMAN DISPOS VEIN STRIP |
| Baseline Generic Name | STRIPPER, VEIN, DISPOSABLE |
| Baseline Model No | NA |
| Baseline Catalog No | 83-4031 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-01-16 |