MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2008-05-12 for CODMAN DISPOS VEIN STRIP 63-4031 manufactured by Codman & Shurtleff, Inc..
[16832787]
Affiliate reports the olive came off during surgery in tunnel when removing catheter, therefore, x-ray to find 2x 1. 5 incisions to retrieve olive. 1. 5 to 2 hours extra surgery. Pt was stable immediately following surgery.
Patient Sequence No: 1, Text Type: D, B5
[16982755]
Upon completion of the investigation a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2008-00122 |
| MDR Report Key | 1047794 |
| Report Source | 01,07 |
| Date Received | 2008-05-12 |
| Date of Event | 2008-04-15 |
| Date Mfgr Received | 2008-04-15 |
| Date Added to Maude | 2008-10-23 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW KING |
| Manufacturer Street | 325 PARAMOUNT DR. |
| Manufacturer City | RAYNHAM MA 027670350 |
| Manufacturer Country | US |
| Manufacturer Postal | 027670350 |
| Manufacturer Phone | 5088283106 |
| Manufacturer G1 | CODMAN & SHURTLEFF, INC. |
| Manufacturer Street | 325 PARAMOUNT DR. |
| Manufacturer City | RAYNHAM MA 02767035 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 0350 |
| 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 | 2008-05-12 |
| Model Number | NA |
| Catalog Number | 63-4031 |
| Lot Number | GX555 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1041333 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-05-12 |