MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. BIOMEND EXTEND; COLLAGEN PERIODONTAL MEMBRANE

Catalog Number	0140Z
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the production records confirmed that the product met release criteria.Additional qc testing of reserve samples were found to be conforming and met release criteria.
Event or Problem Description
The clinician claimed that there was a failure with the product.Several unsuccessful attempts were made to obtain additional information.It is unknown if there was any patient involvement or any adverse events associated with this incident.

• Brand Name: BIOMEND EXTEND
• Common Device Name: COLLAGEN PERIODONTAL MEMBRANE
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• MDR Report Key: 9512431
• Report Number: 2249852-2019-00024
• Device Sequence Number: 2703006
• Product Code: NPL
• UDI-Device Identifier: 00813954020471
• UDI-Public: 00813954020471
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K003339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 0140Z
• Device Lot Number: CDMEN19A2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 12/23/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other