WEIL BLAKESLY THRU CUT 230728

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 2012-11-09 for WEIL BLAKESLY THRU CUT 230728 manufactured by Gyrus Medical Gmbh.

Event Text Entries

[21019232] Instrument broke inside the pt. Reporter believes that all pieces were retrieved.
Patient Sequence No: 1, Text Type: D, B5

[21307709] Evaluated by gyrus medical (b)(4), damaged by normal wear and tear.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 1037007-2012-00006
• MDR Report Key: 2834798
• Report Source: 06
• Date Received: 2012-11-09
• Date of Report: 2012-08-15
• Date of Event: 2012-08-15
• Date Mfgr Received: 2012-08-15
• Date Added to Maude: 2013-02-15
• 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: 0
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: DOLAN MILLS
• Manufacturer Street: 2925 APPLING RD
• Manufacturer City: BARTLETT TN 38133
• Manufacturer Country: US
• Manufacturer Postal: 38133
• Manufacturer Phone: 9013730200
• Manufacturer G1: GYRUS MEDICAL GMBH
• Manufacturer Street: GOTENSTR 3
• Manufacturer City: BUTTLINGEN D-78532
• Manufacturer Country: GM
• Manufacturer Postal Code: D-78532
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: WEIL BLAKESLY THRU CUT
• Product Code: KAE
• Date Received: 2012-11-09
• Returned To Mfg: 2012-09-06
• Catalog Number: 230728
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: GYRUS MEDICAL GMBH
• Manufacturer Address: TUTTLINGEN GM

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2012-11-09