MAUDE Adverse Event Report: KONTOUR SUSTAIN; COLLAGEN DENTAL MEMBRANE- PORCINE TYPE I COLLAGEN

Model Number	KRM3040
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the product was used but did not appear to have been resorbed which caused irritation and infection.The area was additionally debrided and the membrane was replaced.

• Brand Name: KONTOUR SUSTAIN
• Common Device Name: COLLAGEN DENTAL MEMBRANE- PORCINE TYPE I COLLAGEN
• MDR Report Key: 11440252
• Report Number: 2249852-2021-00005
• Device Sequence Number: 3539528
• Product Code: NPL
• UDI-Device Identifier: 10841307130567
• UDI-Public: 10841307130567
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K110600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 06/30/2020
• Device Model Number: KRM3040
• Device Catalogue Number: KRM3040
• Device Lot Number: PTM17C1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2021
• Initial Report FDA Received Date: 03/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention