COLLAPLUG 0102

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2013-05-16 for COLLAPLUG 0102 manufactured by Integra Lifesciences Corporation.

Event Text Entries

[21659672] It was reported "the office had several implant failures and reports of fever from this lot of collaplugs. " numerous attempts requesting additional clinical information were made by integra.
Patient Sequence No: 1, Text Type: D, B5

[21893335] The device involved in the reported incident is not available 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: 1121308-2013-00009
• MDR Report Key: 3122082
• Report Source: 06,08
• Date Received: 2013-05-16
• Date of Report: 2013-05-16
• Date Mfgr Received: 2013-05-08
• Date Added to Maude: 2013-05-22
• 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: COLLAPLUG
• Generic Name: DENTAL PRODUCTS
• Product Code: LPG
• Date Received: 2013-05-16
• Catalog Number: 0102
• Lot Number: 1104500
• 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
• Manufacturer Address: PLAINSBORO NJ 08536 US 08536

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2013-05-16