MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. DURAMATRIX SUTURABLE; COLLAGEN DURA MEMBRANE

Catalog Number	DMS45
Medical Device Problem Code	Hole In Material (1293)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/09/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Clinician observed a hole in the center of the membrane.A revision surgery was performed to remove and replace the membrane with another duramatrix product.Patient was reported to be in good condition at the time of report.

• Brand Name: DURAMATRIX SUTURABLE
• Common Device Name: COLLAGEN DURA MEMBRANE
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• MDR Report Key: 6555904
• Report Number: 2249852-2017-00012
• Device Sequence Number: 980940
• Product Code: GXQ
• UDI-Device Identifier: 00813954020426
• UDI-Public: 00813954020426
• Combination Product (Y/N): N
• PMA/510(K) Number: K141608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/09/2017

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: Physician
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: DMS45
• Device Lot Number: 1607291121
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other