MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. RCT RESORBABLE COLLAGEN TAPE; COLLAGEN WOUND DRESSING - ORAL

Model Number	5091000
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional clarification from the clinician is pending.Testing of qc reserve samples is on-going.
Event or Problem Description
The doctor stated that the patients, who had collagen tape placed, had dry sockets with grey purulent material.One patient had multiple extractions and developed dry socket/infection in the upper quadrant where they placed the collagen tape.Dry socket packs were placed to circumvent this complication.There was no delay in healing or patient injury reported.
Additional Manufacturer Narrative
Additional clarification from the clinician has not been received.Additional qc testing of a reserve sample for sterility confirmed that the product met acceptance criteria.

• Brand Name: RCT RESORBABLE COLLAGEN TAPE
• Common Device Name: COLLAGEN WOUND DRESSING - ORAL
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland, nj
• MDR Report Key: 9771255
• Report Number: 2249852-2020-00003
• Device Sequence Number: 16787847
• Product Code: KGN
• UDI-Device Identifier: 00614950007233
• UDI-Public: 00614950007233
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K040403
• 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,Followup
• Report Date (Section B): 03/13/2020

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: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 5091000
• Device Catalogue Number: 5091000
• Device Lot Number: DWTN18P3
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 03/13/2020
• 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