BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT

    MDR report key: 5704410 · Received June 7, 2016

    Report

    Report Number
    2210968-2016-09570
    Event Type
    Injury
    Date Received
    June 7, 2016
    Report Date
    June 17, 2016
    Manufacturer
    ETHICON SARL
    Product Code
    LMF
    PMA / PMN Number
    N12159
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT TO THE FDA: 06/07/2016. (B)(4). ATTEMPTS HAVE BEEN 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. 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 PRODUCT CODE AND LOT NUMBER OF THE SURGICEL? WHAT WAS THE INTENDED USE OF THE SURGICEL? WHERE WAS THE SURGICEL USED (ON WHAT TISSUE)? HOW MUCH SURGICEL WAS USED DURING THE PROCEDURE? WAS THE SURGICEL PRODUCT LEFT IN PLACE? WHEN DID THE PATIENT PRESENT WITH SYMPTOMS? HAS ANY SURGICAL OR MEDICAL INTERVENTION BEEN TAKEN AS A RESULT? IF YES, PLEASE LIST. WERE ANY OTHER HEMOSTATIC AGENTS USED DURING THE PROCEDURE? IF SO, PLEASE LIST. WHAT IS THE DATE OF THE PROCEDURE? WHAT ARE THE PATIENT DEMOGRAPHICS ¿ GENDER, WEIGHT, HEIGHT, PAST MEDICAL HISTORY? WHAT IS THE PATIENT¿S CURRENT STATUS?

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 07/12/2016. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT IS THE PRODUCT CODE AND LOT NUMBER OF THE SURGICEL? SUGICEL 1901B; LOT: 3891352: EXPIRATION DATE: 2020-10-31. WHAT WAS THE INTENDED USE OF THE SURGICEL? ACHIEVE HEMOSTASIS. WHERE WAS THE SURGICEL USED (ON WHAT TISSUE)? LOCATED ON A FREE LYING DURA. HOW MUCH SURGICEL WAS USED DURING THE PROCEDURE? ONE UNIT OF SURGICAL. WAS THE SURGICEL PRODUCT LEFT IN PLACE? YES IT WAS LEFT IN PLACE. WHEN DID THE PATIENT PRESENT WITH SYMPTOMS? UNKNOWN. WHAT IS THE DATE OF THE PROCEDURE? (B)(6) 2016. WHAT ARE THE PATIENT DEMOGRAPHICS GENDER, WEIGHT, HEIGHT, PAST MEDICAL HISTORY? DOB: (B)(6) 1941. WHAT IS THE PATIENT¿S CURRENT STATUS? PARTIALLY RECOVERED, SLOWLY MOBILIZING. HAND FUNCTION IS STILL MINIMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A CERVICAL LAMINECTOMY PROCEDURE ON UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. TWO DAYS AFTER THE PROCEDURE, THE PATIENT RAPIDLY DEVELOPED TETRAPLEGIA DUE TO COMPRESSION OF THE SPINAL CORD BY SWOLLEN ABSORBABLE HEMOSTAT. IT WAS ALSO REPORTED THAT ABSORBABLE HEMOSTAT WAS NOT PACKED UNDER BONE, BUT LAY LOOSELY OVER THE SPINAL CORD. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357530 SURGICEL ABSORBABLE HEMOSTAT HEMOSTATIC AGENT, ABSORBABLE LMF ETHICON SARL UNK 3891352

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention