BUDDE HALO RETRACTOR A1040

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-09 for BUDDE HALO RETRACTOR A1040 manufactured by Integra Lifesciences Corporation Oh/usa.

Event Text Entries

[77635035] It was reported that the budde halo was broken. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3004608878-2017-00185
• MDR Report Key: 6632314
• Date Received: 2017-06-09
• Date of Report: 2017-05-23
• Date of Event: 2017-05-17
• Date Mfgr Received: 2017-07-03
• Date Added to Maude: 2017-06-09
• 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
• Reporter Occupation: OTHER CAREGIVERS
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: USER ROWENA BUNUAN
• Manufacturer Street: 311 ENTERPRISE DRIVE
• Manufacturer City: PLAINSBORO NJ 08536
• Manufacturer Country: US
• Manufacturer Postal: 08536
• Manufacturer Phone: 6099362393
• Manufacturer G1: INTEGRA LIFESCIENCES CORPORATION OH/USA
• Manufacturer Street: 4900 CHARLEMAR DRIVE
• Manufacturer City: CINCINNATI OH 45227
• Manufacturer Country: US
• Manufacturer Postal Code: 45227
• 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: 2017-06-09
• Catalog Number: A1040
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: INTEGRA LIFESCIENCES CORPORATION OH/USA
• Manufacturer Address: 4900 CHARLEMAR DRIVE 4900 CHARLEMAR DRIVE CINCINNATI OH 45227 US 45227

Patients

Patient Number	Treatment	Outcome	Date
1	0		2017-06-09