BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 10063346 · Received May 15, 2020

    Report

    Report Number
    2210968-2020-03962
    Event Type
    Injury
    Date Received
    May 15, 2020
    Date of Event
    March 16, 2017
    Report Date
    April 27, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT WAS THE INITIAL PROCEDURE AND WHEN THE SUTURE WAS IMPLANTED? HYPOSPADIAS REPAIR ON (B)(6) 2016. WHEN YOU DISCOVERED THE SUTURE STILL IN PLACE - PATIENT HAD DIFFICULTY PASSING URINE POST OP AND HENCE TAKEN TO THEATRE ON (B)(6) 2017 AND WAS FOUND TO HAVE - " A TINY HOLE ABOUT 1 CM PROXIMAL TO TIP OF FORESKIN VENTRALLY - KEPT OPEN BY A SUTURE - WHICH WAS REMOVED" BUT THEN AGAIN PRESENTED AND WAS NOTED TO RESIDUAL SUTURE IN (B)(6) 2020. REFERRED BACK TO HCP FOR THE PRODUCT CODE AND BATCH NUMBER BUT WHEN THE ISSUE WAS FIRST REPORTED, THEY WERE UNABLE TO PROVIDE THE PRODUCT CODE OR THE BATCH NUMBER AS THE NOTES FROM THE ORIGINAL PROCEDURE JUST SAID PDS SUTURE USED. WILL REPORT BACK IF ABLE TO DISCOVER ANY FURTHER INFORMATION. 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. WAS MEDICAL OR SURGICAL INTERVENTION PERFORMED FOR THE RESIDUAL SUTURE FOUND IN (B)(6) 2020? IF YES, PLEASE DESCRIBE. THE PATIENT DEMOGRAPHIC INFO: AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE WAS THE DEVICE REMOVED AND PATIENT RE-SUTURED DURING RETURN TO THE OPERATING THEATER IN (B)(6) 2017? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT¿S CURRENT STATUS? NOTE: EVENT RELATED TO (B)(6) 2020 EVENT REPORTED VIA MW# 2210968-2020-04295. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. 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 Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 6/29/2020. ADDITIONAL INFORMATION: A2, A3, A4, H6. ADDITIONAL H6 PATIENT CODE: 1862, 2119, 3189 - SURGICAL INTERVENTION. ADDITIONAL H6 DEVICE CODE: 2993. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: Q. WAS MEDICAL OR SURGICAL INTERVENTION PERFORMED FOR THE RESIDUAL SUTURE FOUND IN (B)(6) 2020? A: YES, TAKEN TO THEATRE IN (B)(6) 2020: FINDINGS - 1 STITCH NOTED AT DISTAL URETHRA (ALONG PREVIOUS URETHROPLASTY). GRASPED AND PULLED OUT COMPLETELY. Q: THE PATIENT DEMOGRAPHIC INFO AT THE TIME OF INDEX PROCEDURE. A: AGE (2 YRS2 MONTHS), GENDER (MALE), WEIGHT (15KG) , BMI (NOT KNOWN) Q: WAS THE DEVICE REMOVED AND PATIENT RE-SUTURED DURING RETURN TO THE OPERATING THEATRE IN (B)(6) 2017? A: THE SUTURE WAS REMOVED BUT THE HOLE WAS NOT SUTURED BACK. Q: OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? A: NO RELEVANT MEDICAL /MEDICATION HISTORY. Q: WHAT IS THE PHYSICIAN'S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? A: IN MY OPINION, PERSISTENCE OF SUTURE LED TO URETHRAL FISTULA FORMATION. Q: WHAT IS THE PATIENT'S CURRENT STATUS? A: PT HAS NOT BEEN SEEN SINCE THEN. 1. OPERATION: ON (B)(6) 2016 ORIGINAL HYPOSPADIAS REPAIR WHEN SEEN IN (B)(6) 2017- HE HAS HAD LOTS OF DIFFICULTIES SINCE HIS OPERATION. HE CRIES WHEN HE PASSES URINE AND HE HAS HAD 3 LOTS OF INFECTION REQUIRING ANTIBIOTICS. DURING THE INFECTION HIS PENIS AND FORESKIN SWELLS WITH REDNESS AND INFLAMMATION. ON EXAMINATION TODAY THERE WAS EVIDENCE OF A URETHRAL FISTULA. 2. OPERATION - EUA + CALIBRATION (B)(6) 2017: (FINDINGS AT OPERATION: A TINY HOLE ABOUT 1 CM PROXIMAL TO TIP OF FORESKIN VENTRALLY - KEPT OPEN BY A SUTURE - REMOVED) 3. REPAIR OF DISTAL SHAFT FISTULA (B)(6) 2017: (FINDINGS AT OPERATION: TINY FISTULA AT DISTAL SHAFT. SUTURE WITH KNOT FROM PREVIOUS REPAIR SEEN AT THE SITE OF FISTULA AT THE URETHRAL LEVEL. SUTURE KNOT REMOVED. ) 4. THE PATIENT PRESENTED IN (B)(6) 2020 - COMPLAINING OF SOME DISCOMFORT PASSING URINE AND THE STITCH WAS HANGING OUT THE END OF HIS PENIS FROM THE MEATUS. THE END OF THE STITCH WAS CUT WITH SCISSORS IN A+E. TAKEN TO THEATRE IN (B)(6) 2020: FINDINGS - 1 STITCH NOTED AT DISTAL URETHRA (ALONG PREVIOUS URETHROPLASTY). GRASPED AND PULLED OUT COMPLETELY. THE FOLLOWING INFORMATION WAS REQUESTED BUT UNAVAILABLE: DATES OF THE INFECTIONS? WERE CULTURES PERFORMED? IF YES, RESULTS? WAS RE-SUTURING PERFORMED DURING THE REPAIR OF DISTAL SHAFT IN DEC 2017? IF YES, WAS THE SUTURE USED AN ETHICON DEVICE? IF YES, PRODUCT CODE/LOT? WAS THE STITCH FOUND IN APRIL 2020 FROM THE INITIAL REPAIR IN OCT 2016 OR FROM A REPAIR PERFORMED IN DEC 2017? THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? ON WHAT TISSUE WAS THE SUTURE USED? WHAT WAS THE TISSUE CONDITION, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? WERE BOTH PDS II 6.0 AND 7.0 USED ON THIS PATIENT AND FOUND NOT ABSORBED? PRODUCT CODE AND LOT NUMBER? IF APPLICABLE, WILL PRODUCT BE RETURNED, RETURN DATE, TRACKING INFORMATION? 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, 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. NOTE: EVENT RELATED TO JANUARY 2017 EVENT REPORTED VIA MW# 2210968-2020-04897. EVENT RELATED TO MARCH 2017 EVENT REPORTED VIA MW# 2210968-2020-03962. EVENT RELATED TO DEC 2017 EVENT REPORTED VIA MW# 2210968-2020-04900. EVENT RELATED TO APRIL 2020 EVENT REPORTED VIA MW# 2210968-2020-04295.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. 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 INDEX SURGICAL PROCEDURE? THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? ON WHAT TISSUE WAS THE SUTURE USED? WHAT WAS THE TISSUE CONDITION, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? WHAT WERE THE CURRENT SYMPTOMS FOLLOWING THE INDEX SURGICAL PROCEDURE? WHAT WAS THE ONSET DATE OF SYMPTOMS FOLLOWING THE INDEX SURGICAL PROCEDURE? WHAT WERE THE DATES THAT THE PATIENT WAS RETURNED TO THE OPERATING THEATER? WHAT WAS THE INDICATION FOR THE PATIENT¿S RETURN TO THE OPERATING THEATER? DID THE PATIENT UNDERGO AN ADDITIONAL SURGICAL PROCEDURE UPON RETURN TO THE OPERATING THEATER? WAS THE DEVICE REMOVED AND PATIENT RE-SUTURED DURING RETURN TO THE OPERATING THEATER? WHAT WAS THE APPEARANCE OF THE SUTURE DURING THE REOPERATION? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? WERE BOTH PDS II 6.0 AND 7.0 USED ON THIS PATIENT AND FOUND NOT ABSORBED? PRODUCT CODE AND LOT NUMBER? IF APPLICABLE, WILL PRODUCT BE RETURNED, RETURN DATE, TRACKING INFORMATION? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT¿S CURRENT STATUS? IT WAS REPORTED SLOW ABSORPTION OF SUTURE. TWO PICTURES WERE PROVIDED FOR ANALYSIS. UPON VISUAL INSPECTION OF THE PICTURES, ONE SUTURE PIECE WITH A KNOT INSIDE A PETRIDISH COULD BE OBSERVED. IN ADDITION, THE SECOND IMAGE IS NOT CLEAR. HOWEVER, NO CONCLUSION COULD BE REACH AS THE SAMPLE WAS NOT RETURNED FOR ANALYSIS. ABSORPTION OF PDS SUTURE IS ESSENTIALLY COMPLETE BETWEEN 182- AND 238-DAYS POST OPERATION. THE MANUFACTURING RECORDS COULDN'T BE REVIEWED AS THE BATCH NUMBER IS UNKNOWN. THE IMPLANTATION TIME COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS REPORTED TO BE A 7.0/6.0 SUTURE. THE PATIENT RETURNED TO THE THEATRE ON MORE THAN ONE OCCASION AND ON EXAMINATION IT WAS FOUND THAT THE SUTURE REMNANT WAS IN PLACE AND NOT ABSORBED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525634 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 26 MO Required Intervention