MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. KARL SCHUMACHER PLUG; COLLAGEN DENTAL WOUND DRESSINGS - BOVINE DERMIS

Model Number	RCWP0001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Swelling/ Edema (4577)
Date of Event	08/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Limited information regarding event was provided.During initial intake, customer reported patient experienced allergic reaction.It was later clarified patient had surgical extraction of tooth #30 on (b)(6) 2023.Multiple products were used during the procedure, including the karl schumacher plug and other, unspecified products.At the follow-up visit on (b)(6) 2023 the patient had a swollen cheek.A second follow-up visit on (b)(6) 2023 was conducted once patient stopped the steroids; cheek became "severely swollen." customer stated patient was sent to an oral surgery specialist for additional follow-up.The patient was also advised if the allergic reaction continued to go to the hospital.Additional information was requested multiple times, including: the results from the oral surgeon follow-up, the other products used in the initial procedure, the type and dosage of steroids prescribed to the patient after the initial procedure, and the current patient status.Customer was unable to confirm the requested information.The customer did however clarify it is believed the patient's allergic reaction was not caused by the karl schumacher plug and the patient may have had an infection prior to the device being placed in the initial procedure on (b)(6) 2023.Customer stated no additional information will be provided.

• Brand Name: KARL SCHUMACHER PLUG
• Common Device Name: COLLAGEN DENTAL WOUND DRESSINGS - BOVINE DERMIS
• 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: 17627040
• Report Number: 2249852-2023-00012
• Device Sequence Number: 7545352
• Product Code: KGN
• UDI-Device Identifier: 00842517100053
• UDI-Public: (01)00842517100053(17)231031(10)BDDWP20M2;(01)00842517100060(17)231031(10)BDDWP20M2
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K152600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/25/2023

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: 10/31/2023
• Device Model Number: RCWP0001
• Device Catalogue Number: RCWP0001
• Device Lot Number: BDDWP20M2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2020
• 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 Age: 63 YR
• Patient Sex: Female