IDRT-TS (INTL) SINGLE 2X2 82021

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 2014-04-02 for IDRT-TS (INTL) SINGLE 2X2 82021 manufactured by Integra Lifesciences Corp..

Event Text Entries

[20460609] It was reported that 'during the surgery when the package was opened, creases were admitted in the first idrt. Another idrt was opened and used to complete the surgery. '
Patient Sequence No: 1, Text Type: D, B5

[20494550] To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 1121308-2014-00013
• MDR Report Key: 3818580
• Report Source: 01,08
• Date Received: 2014-04-02
• Date of Report: 2014-03-12
• Date Mfgr Received: 2014-03-12
• Date Added to Maude: 2014-06-04
• 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: CAREN FINKELSTEIN
• Manufacturer Street: 315 ENTERPRISE DRIVE
• Manufacturer City: PLAINSBORO NJ 08536
• Manufacturer Country: US
• Manufacturer Postal: 08536
• Manufacturer Phone: 6099362341
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: IDRT-TS (INTL) SINGLE 2X2
• Generic Name: IDRT-TS
• Product Code: MGR
• Date Received: 2014-04-02
• Catalog Number: 82021
• Lot Number: 105NA0277860
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: INTEGRA LIFESCIENCES CORP.
• Manufacturer Address: PLAINSBORO NJ 08536 US 08536

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-04-02