BUDDE HALO RETRACTOR A1040

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2014-06-11 for BUDDE HALO RETRACTOR A1040 manufactured by Integra Lifesciences Corporation Oh/usa.

Event Text Entries

[16849327] Two budde halo components were found defective upon incoming inspection. The complaints were described as 438b1010 starburst teeth has rusted and the spring is not attached. A 438a 1024 halo adjustment wrench is rusted. There was no patient contact reported with this complaint.
Patient Sequence No: 1, Text Type: D, B5

[17079149] To date, the device involved in the reported incident has not been received for eval. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 3004608878-2014-00088
• MDR Report Key: 3994698
• Report Source: 01,08
• Date Received: 2014-06-11
• Date of Report: 2014-05-15
• Date Mfgr Received: 2014-05-15
• Date Added to Maude: 2014-08-18
• 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: LINDA SERENTINO
• Manufacturer Street: 315 ENTERPRISE DRIVE
• Manufacturer Phone: 6099365560
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BUDDE HALO RETRACTOR
• Generic Name: RETRACTOR SYSTEMS
• Product Code: GZT
• Date Received: 2014-06-11
• Catalog Number: A1040
• Lot Number: 139
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: INTEGRA LIFESCIENCES CORPORATION OH/USA
• Manufacturer Address: CINCINNATI OH 45227 US 45227

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-06-11