BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SFX SPI MCRYL+ UNI 18IN 3-0 SA PS PRM MP

    MDR report key: 14251861 · Received April 29, 2022

    Report

    Report Number
    2210968-2022-03150
    Event Type
    Injury
    Date Received
    April 29, 2022
    Date of Event
    January 1, 2022
    Report Date
    April 29, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031236660
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 4/29/2022. THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. (B)(4). DEVICE NOT RETURNED. ATTEMPTS ARE BEING MADE TO RETRIEVE THE DEVICE. 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.ADDITIONAL INFORMATION: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: BATCH RBBEQM MFG DATE: (B)(6) 2021, EXP DATE: 01/31/2023. BATCH QKBDRK MFG DATE: (B)(6) 2020, EXP DATE: 08/31/2022. BATCH RKBATZ, MFG DATE: (B)(6) 2021, EXP DATE: 08/31/2023. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE 3 POSSIBLE BATCH NUMBERS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: SXMP1B111: LOT: RKBATZ. SXMP1B111: LOT: QKBDRK. XMP1B111: LOT:RBBEQM. COULD YOU INDICATE TO WHICH COMPLAINT THIS GIVEN INFORMATION BELONGS?NO INFORMATION ON WHICH LOT WAS USED ON WHICH PATIENT. 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. WHAT IS THE PROCEDURE NAME? WHAT IS THE PROCEDURE DATE? WHAT DATE DID THE REACTION OCCUR ON?WHAT DOES THE REACTION LOOK LIKE AND HOW LARGE OF AN AREA DOES THE REACTION COVER?LOCATION OF THE INFECTION: DO YOU HAVE ANY PICTURES OF THE REACTION/INFECTION? PLEASE PROVIDE THE MEDICATION NAME, ROUTE AND DOSE: WERE THERE SIGNS OR SYMPTOMS OF INFECTION PRIOR TO THE PROCEDURE? WERE CULTURES PERFORMED? IF YES, RESULTS? WHAT IS THE MOST CURRENT PATIENT STATUS? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFECTION PRIOR TO THIS SURGICAL PROCEDURE? PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE: THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? CAN YOU IDENTIFY THE PRODUCT CODE AND LOT NUMBER OF THE PRODUCT THAT WAS USED? DEVICE RETURN STATUS: NOTE: EVENT REPORTED IN 2210968-2022-03147, 2210968-2022-03148, 2210968-2022-03149, AND 2210968-2022-03151.TRADE NAME: IRGACARE®. ACTIVE INGREDIENT(S): TRICLOSAN. DOSAGE FORM: SUTURE/SOLID/ PARENTERAL. STRENGTH 2360 G/M.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. POST-OP, THE PATIENT HAD A SCARRING PROBLEM. THE PATIENT HAD A SUPERFICIAL INFECTION TREATED WITH ANTIBIOTICS. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118162 SFX SPI MCRYL+ UNI 18IN 3-0 SA PS PRM MP SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID GAM ETHICON INC. SXMP1B111 10705031236660

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention