BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED*SURG MESH/MULTI LYR

    MDR report key: 10953576 · Received December 5, 2020

    Report

    Report Number
    2210968-2020-09615
    Event Type
    Injury
    Date Received
    December 5, 2020
    Date of Event
    January 1, 2020
    Report Date
    November 7, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    UDI-DI
    10705031047792
    PMA / PMN Number
    K060713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 12/28/2020.   THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: THE PATIENT DEMOGRAPHIC INFO: AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE DATE AND NAME OF INITIAL SURGICAL PROCEDURE THE DIAGNOSIS AND INDICATION FOR THE INITIAL SURGICAL PROCEDURE? WHAT WERE CURRENT SYMPTOMS FOLLOWING THE INDEX SURGICAL PROCEDURE? ONSET DATE? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS PRODUCT LOT # WHAT IS PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT INVOLVED? WHAT MEDICAL INTERVENTION WAS PERFORMED? RESULTS? WERE CULTURES PERFORMED? RESULTS? WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFECTION PRIOR TO THIS SURGICAL PROCEDURE? DID THE PATIENT RECEIVE ANY PROPHYLACTIC ANTIBIOTICS PRE-, INTRA- OR POST-OPERATION? WHAT IS THE PATIENT'S CURRENT STATUS? THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE PATIENT DEMOGRAPHIC INFO: AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE DATE AND NAME OF INITIAL SURGICAL PROCEDURE THE DIAGNOSIS AND INDICATION FOR THE INITIAL SURGICAL PROCEDURE? WHAT WERE CURRENT SYMPTOMS FOLLOWING THE INDEX SURGICAL PROCEDURE? ONSET DATE? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS PRODUCT LOT # WHAT IS PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT INVOLVED? WHAT MEDICAL INTERVENTION WAS PERFORMED? RESULTS? WERE CULTURES PERFORMED? RESULTS? WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFECTION PRIOR TO THIS SURGICAL PROCEDURE? DID THE PATIENT RECEIVE ANY PROPHYLACTIC ANTIBIOTICS PRE-, INTRA- OR POST-OPERATION? WHAT IS THE PATIENT'S CURRENT STATUS? IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR ON AN UNKNOWN DATE AND THE MESH WAS IMPLANTED. IT WAS REPORTED THAT WHEN REOPERATING A PATIENT 4 MONTHS AFTER HAVING BEEN OPERATED ON FOR A HERNIA WITH A PROCEED MESH. IT PRESENTS A CAVITY BETWEEN THE SUBCUTANEOUS CELLULAR TISSUE AND THE MESH, FORMING A KIND OF CAPSULE WITH A LITTLE LIQUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1419229 PROCEED*SURG MESH/MULTI LYR MESH, SURGICAL, POLYMERIC FTL ETHICON INC. PCDW1 10705031047792

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention