MAUDE Adverse Event Report: COLLAGEN MATRIX, INC NUOSS COLLAGEN; OSTEROGUIDE ANORGANIC BONE MINERAL PRODUCTS (DENTAL)

Lot Number BMBU19J1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Type  Injury  

Event Description

Nuoss collagen block was used on patient.Based off limited information provided, patient developed a hematoma post-op from graft surgery.It was reported the doctor felt that contributed to some of the bone loss.Patient rinsed with baking soda rinse post-op, not an antimircrobial rinse.Patient was prescribed antibiotics.No additional information was provided on patient outcome or patient status.

• Brand Name: NUOSS COLLAGEN
• Type of Device: OSTEROGUIDE ANORGANIC BONE MINERAL PRODUCTS (DENTAL)
• 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 road; oakland, NJ 07436
• MDR Report Key: 15545288
• MDR Text Key: 301205323
• Report Number: 2249852-2022-00032
• Device Sequence Number: 1
• Product Code: NPM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 08/31/2022
• Device Lot Number: BMBU19J1
• Date Manufacturer Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other