BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK SUTURE

    MDR report key: 1273890 · Received December 24, 2008

    Report

    Report Number
    2210968-2008-01333
    Event Type
    Injury
    Date Received
    December 24, 2008
    Date of Event
    November 1, 2008
    Report Date
    November 24, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GAP
    PMA / PMN Number
    N11397
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 12/23/2008. CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. THE ACTUAL DEVICE ASSOCIATED WITH THIS EVENT IS NOT KNOWN. INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE PRODUCTS: LOT: 974403, MFG: 04/01/2008, EXP: 04/30/2013. LOT: 112877, MFG: 08/01/2008, EXP: 08/31/2013. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT PRESENTED WITH AN "ALLERGIC" REACTION THAT IS DESCRIBED AS BLEEDING, REDNESS, EDEMA AND WOUND DEHISCENCE TWO TO THREE DAYS FOLLOWING DENTAL SURGERY. THE PATIENT UNDERWENT A CURETTAGE OF THE SURGICAL SITE FOLLOWED BY A SALINE RINSE AND SURGICAL REPAIR. IMPROVEMENT WAS REPORTED THE DAY AFTER SUTURE REMOVAL AND REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILK SUTURE SUTURE, NON-ABSORBABLE GAP ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention