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	Headache (1880); Inflammation (1932)
Date of Event	03/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor reported after grafting using rcm6 membrane during a surgical extraction and bone graft, there was swelling observed in surgical site of patient.On (b)(6) 2022, 7 days after the procedure, patient reported soreness.On (b)(6) 2022, 16 days after the procedure, patient reported headaches and a loss of taste and smell.Patient was prescribed antibiotics on (b)(6) 2022 and symptoms improved.
Additional Manufacturer Narrative
Additinal quality control testing of samples is pending.
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 road; oakland NJ 07436
• Manufacturer (Section G): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• Manufacturer Contact: peggy hansen ; 15 thornton road; oakland, NJ 07436
• MDR Report Key: 14253103
• Report Number: 2249852-2022-00004
• Device Sequence Number: 4398545
• 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: 5093000
• Device Lot Number: CMN210604
• 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