MAUDE Adverse Event Report: 3-D MATRIX, INC PURASINUS

Model Number	D651-005
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	11/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initially, 3-d matrix (3dm) become aware of this event on or before 18nov2021.The previous quality assurance manager attempted to contact the complainant on 18nov2021.No further evidence of contact between 3dm and complainant.On 20apr2022, the new quality and regulatory manager became aware of this complaint and immediately attempted to contact the complainant.Between 20apr2022 and 02may2022, 3dm made three attempts to discuss with the complainant with the final attempt resulting in a meeting scheduled.The complainant was not able to attend the meetings but on 18may2022 the sales manager spoke to her about the incident and the background information about the event was provided at that time.On 03may2022, 3dm began the installation process to submit reports electronically.The process was not verified as completed until 01jul2022 and the quality and regulatory manager began working on the report at that time.
Event or Problem Description
A doctor reported a patient involved in a surgical procedure with purasinus required hospitalization due to a re-bleed.

• Brand Name: PURASINUS
• Common Device Name: PURASINUS
• Manufacturer (Section D): 3-D MATRIX, INC; 1234 chestnut st; suite 205; newton MA 02464
• Manufacturer (Section G): 3-D MATRIX; 1234 chestnut street; suite 205; newton MA 02464
• Manufacturer Contact: alan miskewicz ; 1234 chestnut street; suite 205; newton, MA 02464 ; 7813739020
• MDR Report Key: 15102080
• Report Number: 3015528146-2022-00001
• Device Sequence Number: 5438112
• Product Code: NHB
• UDI-Device Identifier: 00860001820836
• UDI-Public: 00860001820836
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K183015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/11/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/26/2022
• Device Model Number: D651-005
• Device Catalogue Number: 651-005
• Device Lot Number: 21B16A30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE KNOWN
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 60 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 45 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White