MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2010-12-02 for BOOKWALTER RET ML BL 3X6 50-4567 manufactured by Codman & Shurtleff, Inc..
[1745278]
Affiliate reported that the blade broke off the handle during use in a gastric operation. It was reported that the blades were recovered, however, as a result, surgery was delayed.
Patient Sequence No: 1, Text Type: D, B5
[8868555]
Upon completion of the investigation, a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 1226348-2010-00395 |
MDR Report Key | 1937806 |
Report Source | 01,07 |
Date Received | 2010-12-02 |
Date of Event | 2010-09-16 |
Date Mfgr Received | 2010-11-10 |
Date Added to Maude | 2011-01-24 |
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 02767 |
Manufacturer Country | US |
Manufacturer Postal | 02767 |
Manufacturer Phone | 5088283106 |
Manufacturer G1 | CODMAN & SHURTLEFF, INC. |
Manufacturer Street | 325 PARAMOUNT DR. |
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 | BOOKWALTER RET ML BL 3X6 |
Generic Name | RETRACTORS |
Product Code | DWH |
Date Received | 2010-12-02 |
Model Number | NA |
Catalog Number | 50-4567 |
Lot Number | 093 |
ID Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | CODMAN & SHURTLEFF, INC. |
Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US 02767 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2010-12-02 |