BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXCEL 18IN(45CM) 5-0 WHT

    MDR report key: 11529885 · Received March 19, 2021

    Report

    Report Number
    2210968-2021-02561
    Event Type
    Injury
    Date Received
    March 19, 2021
    Date of Event
    January 1, 2021
    Report Date
    March 8, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    UDI-DI
    10705031240407
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO FDA: 04/13/2021. 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 INC, 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 INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DATE OF INDEX SURGICAL PROCEDURE? SURGICAL PROCEDURE DATE IS BETWEEN (B)(6). THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? PEDIATRIC SLING APPLICATION FOR DROOPY EYELID WHAT WERE CURRENT SYMPTOMS FOLLOWING THE INDEX SURGICAL PROCEDURE? ONSET DATE? EYELID ABSCESS AND INFECTION. PATIENT SYMPTOMS MANIFESTATIONS (LOCATION, SEVERITY, APPEARANCE, SYSTEMIC OR LOCAL REACTION)? EYELID ABSCESS. DATE - TIME OF ONSET OF INFECTION FROM THE SURGICAL PROCEDURE? THE TYPE OF INFECTION IS A SLOW INFECTION THAT DEVELOPS WITHIN ABOUT 1 MONTH. WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFECTION PRIOR TO THIS SURGICAL PROCEDURE? THERE ARE NO SIGNS OF INFECTION BEFORE SURGERY. DID THE PATIENT RECEIVE ANY PROPHYLACTIC ANTIBIOTICS PRE-, INTRA- OR POST-OPERATION? PROPHYLACTIC ANTIBIOTIC SYRUP WAS USED POSTOPERATIVELY. RESULTS OF THE CULTURES PERFORMED? METHICILLIN SENSITIVE STAPHYLOCOCCUS AUREUS GREW. WHAT MEDICAL INTERVENTION WAS PERFORMED? RESULTS? EYE POMADE AND PROPHYLACTIC ANTIBIOTIC SYRUP WERE USED SIMULTANEOUSLY. AFTER THE SUTURE USED AS A MEDICAL INTERVENTION WAS REMOVED AND THE ABSCESS WAS DRAINED, THE SECOND SURGERY WAS PLANNED. WHAT IS PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? ALTHOUGH THE PHYSICIAN THINKS THAT THE INFECTION MAY BE CAUSED BY THE PATIENT SINCE HE IS A PEDIATRIC PATIENT, HE THINKS THAT THERE MAY HAVE BEEN AN ERROR RELATED TO STERILIZATION IN THE PRODUCTION LINE. WHAT IS THE PATIENT CURRENT STATUS? THE PATIENT'S INFECTION FINDINGS HAVE IMPROVED, BUT HE IS WAITING FOR HIS SECOND SURGERY. PRODUCT LOT NUMBER? PMU444. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH PMU444, X893G AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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 OF INDEX SURGICAL PROCEDURE? THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? WHAT WERE CURRENT SYMPTOMS FOLLOWING THE INDEX SURGICAL PROCEDURE? ONSET DATE? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? PATIENT SYMPTOMS MANIFESTATIONS (LOCATION, SEVERITY, APPEARANCE, SYSTEMIC OR LOCAL REACTION)? PLEASE CLARIFY WHAT IS MEANT BY ¿DEVELOPMENT OF 2 BOWS¿? DATE - TIME OF ONSET OF INFECTION FROM THE SURGICAL PROCEDURE? 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? RESULTS OF THE CULTURES PERFORMED? WHAT MEDICAL INTERVENTION WAS PERFORMED? RESULTS? WHAT IS PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT CURRENT STATUS? PRODUCT LOT NUMBER? HAS PRODUCT BEEN RETURNED? IF SO, PLEASE PROVIDE THE RETURN DATE AND TRACKING INFORMATION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A OPHTHALMIC SURGERY ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. THE PATIENT EXPERIENCED INFECTION AND DEVELOPMENT OF 2 BOWS AFTER OPHTHALMOLOGY. IT WAS REPORTED THAT THE INFECTION REPRODUCED FROM ITS OWN FLORA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427092 ETHIBOND EXCEL 18IN(45CM) 5-0 WHT SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC. X893G PMU444 10705031240407

    Patients

    Seq Age Sex Outcome Treatment
    1