WEITLANER RETR 6-1/2 BLUNT 205156

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-06-19 for WEITLANER RETR 6-1/2 BLUNT 205156 manufactured by Integra York, Pa Inc..

Event Text Entries

[4555918] Customer initially reports that during a right carotid endarterectomy, the weitlaner retractor was passed back to the surgical tech, she notified the surgeon that a piece was missing. Surgeon found broken piece and removed it from the pt, no x-ray was taken and there was no harm to pt.
Patient Sequence No: 1, Text Type: D, B5

[12061169] To date, the device involved in the reported incident has not been received for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 2523190-2014-00042
• MDR Report Key: 3964305
• Report Source: 06
• Date Received: 2014-06-19
• Date of Report: 2014-05-19
• Date of Event: 2014-05-19
• Date Mfgr Received: 2014-06-04
• Date Added to Maude: 2014-08-06
• 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: SANDRA LEE
• Manufacturer Street: 315 ENTERPRISE DR
• Manufacturer Phone: 6099366828
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: WEITLANER RETR 6-1/2 BLUNT
• Generic Name: CARDIOVASCULAR GENERAL
• Product Code: HBG
• Date Received: 2014-06-19
• Catalog Number: 205156
• Lot Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: INTEGRA YORK, PA INC.
• Manufacturer Address: YORK PA 17402 US 17402

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-06-19