COLLINS RADIOPARENT BLADE 50-8081

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-03-12 for COLLINS RADIOPARENT BLADE 50-8081 manufactured by Codman And Shurtleff - Raynham.

Event Text Entries

[15781139] Affiliate reported that the when the blades were inserted into the retractor body and spread with minor force, one of the two blades broke in pieces, the sternum closed suddenly. Affiliate also reported the texture of the blades appeared to be different.
Patient Sequence No: 1, Text Type: D, B5

[15866091] Upon completion of the investigation, a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 1226348-2012-00126
• MDR Report Key: 2488506
• Report Source: 01,07
• Date Received: 2012-03-12
• Date of Event: 2012-02-12
• Date Mfgr Received: 2012-02-13
• Date Added to Maude: 2012-03-12
• 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: MR MATTHEW KING
• Manufacturer Street: 325 PARAMOUNT DRIVE
• Manufacturer City: RAYNHAM MA 02767
• Manufacturer Country: US
• Manufacturer Postal: 02767
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: COLLINS RADIOPARENT BLADE
• Generic Name: BLADE, SAW, SURGICAL, CARDIOVASCULAR
• Product Code: DWH
• Date Received: 2012-03-12
• Catalog Number: 50-8081
• Lot Number: 123831
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CODMAN AND SHURTLEFF - RAYNHAM
• Manufacturer Address: 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-03-12