MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. NUOSS CANCELLOUS; OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS

Lot Number	BM2CU15K1
Health Effect - Clinical Code	Inflammation (1932)
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient experienced swelling within 24 hours of procedure, no infection was observed.The patient received antibiotics, pain medication and mouthwash.The symptoms subsided within 1 week.

• Brand Name: NUOSS CANCELLOUS
• Common Device Name: OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• MDR Report Key: 7148264
• Report Number: 2249852-2017-00023
• Device Sequence Number: 11288641
• Product Code: NPM
• UDI-Device Identifier: 00614950007516
• UDI-Public: 00614950007516
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K043034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 12/27/2017

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: Dentist
• Device Expiration Date: 11/30/2018
• Device Lot Number: BM2CU15K1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 12/27/2017
• 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: Required Intervention