MAUDE Adverse Event Report: COLLAGEN MATRIX, INC RCM6; COLLAGEN PERIODONTAL MEMBRANE

Model Number	5093000
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); Inflammation (1932)
Date of Event	03/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional quality control testing of samples is pending.
Event or Problem Description
It was reported that a patient claimed that there was drainage and gingival inflammation following a surgical extraction and bone graft procedure in which a rcm6 membrane was used on (b)(6) 2022.Doctor prescribed antibiotics to treat conditions.No delay in surgery or injury reported.No revision or medical intervention required.Patient is doing better as of (b)(6) 2022.
Additional Manufacturer Narrative
Additional quality control testing showed the product was sterile.

• Brand Name: RCM6
• Common Device Name: COLLAGEN PERIODONTAL MEMBRANE
• Manufacturer (Section D): COLLAGEN MATRIX, INC; 15 thornton rd; oakland NJ 07436
• Manufacturer (Section G): COLLAGEN MATRIX, INC.; 15 thornton rd; oakland NJ 07436
• Manufacturer Contact: peggy hansen ; 15 thornton rd; oakland, NJ 07436
• MDR Report Key: 14253098
• Report Number: 2249852-2022-00005
• Device Sequence Number: 19932963
• Product Code: NPL
• UDI-Device Identifier: 00614950007325
• UDI-Public: 00614950007325
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K003339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2022

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
• Device Expiration Date: 07/31/2024
• Device Model Number: 5093000
• Device Catalogue Number: 509-3000
• Device Lot Number: CMN21064
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2021
• 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: Other
• Patient Sex: Female