BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFX SPI PDS+ UNI VIO 12IN 2-0 S/A SH

    MDR report key: 11808954 · Received May 11, 2021

    Report

    Report Number
    2210968-2021-04431
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Date of Event
    April 15, 2021
    Report Date
    January 12, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031235892
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 1/12/2022. THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. PART 4 SUBPART B. 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 REQUESTED, THE FOLLOWING WAS OBTAINED: START DATE: (B)(6) 2021. ALERT DATE: 21 DEC 2021. COUNTRY OF EVENT: US. TYPE OF PROCEDURE: SLEEVE GASTRECTOMY. DATE OF PROCEDURE: (B)(6) 2021. ADVERSE EVENT TERM: GERD REQUIRING PROTONIX. PATIENT DETAILS: PATIENT IDENTIFIER: (B)(6). SEX: FEMALE. AGE (AT TIME OF CONSENT): 32 YEARS. ADDITIONAL EVENT DETAILS: SITE AWARENESS DATE: 29 JUL 2021. END DATE: BLANK. SEVERITY: MILD. IS THE ADVERSE EVENT SERIOUS? NO. DEATH: NO. DATE OF DEATH: BLANK. LIFE-THREATENING ILLNESS OR INJURY: NO. PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR A BODY FUNCTION: NO REQUIRED IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION: NO ADMISSION DATE: BLANK DISCHARGE DATE: BLANK RESULTED IN MEDICAL OR SURGICAL INTERVENTION: NO LED TO FETAL DISTRESS, FETAL DEATH OR A CONGENITAL ABNORMALITY OR BIRTH DEFECT: NO RELATIONSHIP TO STUDY DEVICE: UNLIKELY RELATIONSHIP TO PRIMARY STUDY PROCEDURE: BLANK. INTERVENTION/TREATMENT: NONE: NO. DIAGNOSTIC INTERVENTION: NO. ASPIRATION/DRAINAGE: NO. CULTURE TAKEN: NO. ORAL MEDICATION: YES. INJECTED MEDICATION: NO. PHYSICAL THERAPY: NO. OBSERVATION: NO. BLOOD TRANSFUSION: NO. DRUG THERAPY: NO. DIAGNOSTIC IMAGING: NO. REFERRAL: NO. THERMAL TREATMENTS FOR PAIN MANAGEMENT: NO OUTPATIENT POSTOPERATIVE ANESTHETICS: NO. INTEGRATIVE MEDICINE: NO NON-SURGICAL THERAPY OR INTERVENTION: NO. OTHER: NO. IF OTHER SPECIFY: BLANK. DOES THIS ADVERSE EVENT MEET THE DEFINITION OF A UADE? BLANK. OUTCOME: BLANK. ACCORDING TO THE PROTOCOL AND INSTRUCTIONS FOR USE, IN THE OPINION OF THE INVESTIGATOR, IS THE ADVERSE EVENT EXPECTED/ANTICIPATED: BLANK DID THIS EVENT RESULT IN THE PATIENT'S DISCONTINUATION OF THE STUDY? NO. (B)(6). UPDATED LOG LINE 1. EVENT DETAILS: START DATE: (B)(6) 2021. ALERT DATE: 21 DEC 2021. COUNTRY OF EVENT: US. TYPE OF PROCEDURE: SLEEVE GASTRECTOMY. DATE OF PROCEDURE: (B)(6) 2021. ADVERSE EVENT TERM: GERD REQUIRING PROTONIX. PATIENT DETAILS: PATIENT IDENTIFIER: (B)(6). SEX: FEMALE. AGE (AT TIME OF CONSENT): 32 YEARS. ADDITIONAL EVENT DETAILS: SITE AWARENESS DATE: 29 JUL 2021. END DATE: BLANK. SEVERITY: MILD. IS THE ADVERSE EVENT SERIOUS? NO. DEATH: NO. DATE OF DEATH: BLANK. LIFE-THREATENING ILLNESS OR INJURY: NO. PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR A BODY FUNCTION: NO REQUIRED IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION: NO ADMISSION DATE: BLANK DISCHARGE DATE: BLANK RESULTED IN MEDICAL OR SURGICAL INTERVENTION: NO LED TO FETAL DISTRESS, FETAL DEATH OR A CONGENITAL ABNORMALITY OR BIRTH DEFECT: NO RELATIONSHIP TO STUDY DEVICE: UNLIKELY RELATIONSHIP TO PRIMARY STUDY PROCEDURE: PROBABLE INTERVENTION/TREATMENT: NONE: NO. DIAGNOSTIC INTERVENTION: NO. ASPIRATION/DRAINAGE: NO. CULTURE TAKEN: NO. ORAL MEDICATION: YES. INJECTED MEDICATION: NO. PHYSICAL THERAPY: NO. OBSERVATION: NO. BLOOD TRANSFUSION: NO. DRUG THERAPY: NO. DIAGNOSTIC IMAGING: NO. REFERRAL: NO. THERMAL TREATMENTS FOR PAIN MANAGEMENT: NO OUTPATIENT POSTOPERATIVE ANESTHETICS: NO INTEGRATIVE MEDICINE: NO NON-SURGICAL THERAPY OR INTERVENTION: NO. OTHER: NO. IF OTHER SPECIFY: BLANK. DOES THIS ADVERSE EVENT MEET THE DEFINITION OF A UADE? NO. OUTCOME: RECOVERING/RESOLVING. ACCORDING TO THE PROTOCOL AND INSTRUCTIONS FOR USE, IN THE OPINION OF THE INVESTIGATOR, IS THE ADVERSE EVENT EXPECTED/ANTICIPATED: N/A DID THIS EVENT RESULT IN THE PATIENT'S DISCONTINUATION OF THE STUDY? NO. UPDATED: IF THE EVENT IS SERIOUS AND DEVICE RELATED, ACCORDING TO THE PROTOCOL AND INSTRUCTIONS FOR USE, IN THE OPINION OF THE INVESTIGATOR, IS THE ADVERSE EVENT EXPECTED/ANTICIPATED? BLANK - N/A OUTCOME. BLANK - RECOVERING/RESOLVING RELATIONSHIP TO [PRIMARY STUDY PROCEDURE/APPLICATION OF STUDY DEVICE] - BLANK ¿ PROBABLE. TRADE NAME - IRGACARE®. ACTIVE INGREDIENT(S) ¿ TRICLOSAN. DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL. STRENGTH ¿ 2360 G/M.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 06/10/2021. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. PART 4 SUBPART B. 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. TRADE NAME - IRGACARE®; ACTIVE INGREDIENT(S) ¿ TRICLOSAN; DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL; STRENGTH ¿ = 2360 G/M.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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. COULD YOU PLEASE CONFIRM IF THE SUTURE BROKE OR IF THE SUTURE DETACHED FROM THE NEEDLE AT THE END OF SUTURE LINE? WERE THERE ANY PATIENT CONSEQUENCES? TRADE NAME - IRGACARE®. ACTIVE INGREDIENT(S) ¿ TRICLOSAN. DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL. STRENGTH ¿ = 2360 G/M.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A VERTICAL SLEEVE GASTRECTOMY ON (B)(6) 2021 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE BARBED SUTURE DETACHED FROM THE SHAFT WHILE MANIPULATING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704016 SFX SPI PDS+ UNI VIO 12IN 2-0 S/A SH SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE NEW ETHICON INC. SXPP1B416 QBBDJH 10705031235892

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female