MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-02-09 for JONES FCP BAY 8 1/2.004 80-1852 manufactured by Codman & Shurtleff, Inc..
[584966]
Rep reported that the surgeon is very much accustomed to using codman product, however, when he used the product he explained the teeth were so sharp that they perforated the artery. The patient was fine, however, the surgery was prolonged.
Patient Sequence No: 1, Text Type: D, B5
[7816800]
Codman 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 | 1226348-2007-00054 |
| MDR Report Key | 817364 |
| Report Source | 05,06 |
| Date Received | 2007-02-09 |
| Date Mfgr Received | 2007-01-12 |
| Date Added to Maude | 2007-02-15 |
| 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 | 5088263106 |
| Manufacturer G1 | CODMAN & SHURTLEFF, INC. |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MD 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 | JONES FCP BAY 8 1/2.004 |
| Generic Name | SURGICAL INSTRUMENT MANUAL |
| Product Code | EMF |
| Date Received | 2007-02-09 |
| Returned To Mfg | 2007-01-18 |
| Model Number | NA |
| Catalog Number | 80-1852 |
| Lot Number | 0605N |
| 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 | 804847 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US |
| Baseline Brand Name | JONES FCP BAY 8 1/2.004 |
| Baseline Generic Name | SURGICAL INSTRUMENT MANUAL |
| Baseline Model No | NA |
| Baseline Catalog No | 80-1852 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-02-09 |