BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTATING SURGICAL PUNCH

    MDR report key: 10039764 · Received May 8, 2020

    Report

    Report Number
    2242056-2020-00002
    Event Type
    Injury
    Date Received
    May 8, 2020
    Date of Event
    March 17, 2020
    Report Date
    July 31, 2020
    Manufacturer
    A&E MEDICAL CORPORATION
    Product Code
    LRY
    UDI-DI
    10841291105169
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    A&E COMPLETED A FULL INVESTIGATION OF THE COMPLAINTS. SUMMARY OF FINDINGS ATTACHED. CURRENT PUNCH PRODUCTION TESTS ALL PUNCHES FOR CUT AND ACTIVATION PRIOR TO PACKAGING. CONCLUSION WAS THAT THE VOLUME OF PUNCHES SOLD AND THE VERY LIMITED NUMBER OF COMPLAINTS, THESE FAILURES ARE VERY ISOLATED EVENTS. THE COMPLAINTS DO NOT INDICATE A PATIENT SAFETY RISK. THE USERS CONTINUE TO USE THE PRODUCT AND HAVE NOT HAD SUBSEQUENT CUTTING ISSUES TO DATE. IMPROVEMENTS TO PRODUCTION PROCESS HAVE BEEN IDENTIFIED AND WILL BE IMPLEMENTED AS STATED IN THE REPORT. THIS REPORT CLOSES THE INVESTIGATION AND COMPLAINT. INCIDENT 1: CATALOG: 080-401. DATE OF EVENT: (B)(6) 2020. LOT: 00097. UDI: (B)(4). COMPLAINT RECEIVED: 4/9/20. MANUFACTURED DATE: 12/9/19. EXPIRATION DATE; 11/1/24. DEVICE RETURNED: N/A. INCIDENT 2: CATALOG: 080-401. DATE OF EVENT: (B)(6) 2020. LOT: 00097. UDI: (B)(4). COMPLAINT RECEIVED: 4/14/20. MANUFACTURED DATE: 12/9/19. EXPIRATION DATE; 11/1/24. DEVICE RETURNED: 4/20/20. INCIDENT 3: CATALOG: 080-401. DATE OF EVENT: (B)(6) 2020. LOT: 00406. UDI: (B)(4). COMPLAINT RECEIVED: 4/23/20. MANUFACTURED DATE: 1/7/20. EXPIRATION DATE; 12/1/24. DEVICE RETURNED: 4/30/20.

    Description of Event or Problem · 0

    USER-FACILITY REPORTED TISSUE TEARING WAS OBSERVED ON THREE SEPERATA OCCASIONS.

    Additional Manufacturer Narrative · 1

    USER-FACILITY REPORTED TISSUE TEARING WAS OBSERVED ON THREE SEPARATE OCCASIONS. TWO SUSPECT DEVICES HAVE BEEN RETURNED TO A&E MEDICAL AND WERE OBSERVED TO BE CONTAMINATED WITH RESIDUE APPEARING TO BE BLOOD. ONCE DEVICES ARE DECONTAMINATED AND EVALUATED A FOLLOW-UP REPORT CONCLUDING THE INVESTIGATION WILL BE ISSUED. INCIDENT 1: CATALOG: 080-401, DATE OF EVENT: (B)(6) 2020, LOT: 00097, UDI: (B)(4). COMPLAINT RECEIVED: 4/9/20. MANUFACTURED DATE: 12/9/19. EXPIRATION DATE; 11/1/24. DEVICE RETURNED: N/A. INCIDENT 2: CATALOG: 080-401, DATE OF EVENT: (B)(6) 2020, LOT: 00097, UDI: (B)(4). COMPLAINT RECEIVED: 4/14/20. MANUFACTURED DATE: 12/9/19. EXPIRATION DATE; 11/1/24. DEVICE RETURNED: 4/20/20. INCIDENT 3: CATALOG: 080-401, DATE OF EVENT: (B)(6) 2020, LOT: 00406, UDI: (B)(4). COMPLAINT RECEIVED: 4/23/20. MANUFACTURED DATE: 1/7/20. EXPIRATION DATE; 12/1/24. DEVICE RETURNED: 4/30/20

    Description of Event or Problem · 1

    USER-FACILITY REPORTED TISSUE TEARING WAS OBSERVED ON THREE SEPARATE OCCASIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503693 ROTATING SURGICAL PUNCH SURGICAL PUNCH LRY A&E MEDICAL CORPORATION 080-401 00097 10841291105169

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention