MAUDE Adverse Event Report: TUTOGEN MEDICAL COPIOS PERICARDIUM MEMBRANE; BOVINE PERICARDIUM MEMBRANE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Wound Dehiscence (1154)

Event Date 11/04/2019

Event Type  Injury  

Manufacturer Narrative

Unique identifiers were not provided in order to conduct a comprehensive records re-review.If additional information is provided,a follow-up report will be submitted.

Event Description

An adverse event was reported through a post market survey for copios percardium membrane (cpms) for dental applications performed within the past two years indicated that 70 dental procedures were performed and greater than 1-5% of the patients experienced dehiscence.

• Brand Name: COPIOS PERICARDIUM MEMBRANE
• Type of Device: BOVINE PERICARDIUM MEMBRANE
• Manufacturer (Section D): TUTOGEN MEDICAL; industriestrasse 6; GM
• Manufacturer (Section G): RTI SURGICAL; 11621 research circle; FL
• Manufacturer Contact: charity emmons ; alachua, FL 32615 ; 3864188888
• MDR Report Key: 9401133
• MDR Text Key: 174626013
• Report Number: 3002924436-2019-00017
• Device Sequence Number: 1
• Product Code: NPL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other