BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 19091126 · Received April 11, 2024

    Report

    Report Number
    2210968-2024-04206
    Event Type
    Injury
    Date Received
    April 11, 2024
    Date of Event
    January 23, 2022
    Report Date
    April 11, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. 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. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. RELATED EVENTS CAPTURED VIA 2210968-2024-04207. CITATION: EUROPEAN JOURNAL OF OPHTHALMOLOGY 2022, VOL. 32(6): 3383¿3391. HTTPS://DOI.ORG/10.1177/11206721221085400.

    Description of Event or Problem · 0

    TITLE: PILLAR TARSOCONJUNCTIVAL FLAP: AN ALTERNATIVE APPROACH FOR THE MANAGEMENT OF REFRACTORY CORNEAL ULCER. THIS IS A RETROSPECTIVE, NONCOMPARATIVE, CONSECUTIVE CASE SERIES AIMS TO REPORT THE EFFECTIVENESS OF THE SURGICAL PROCEDURE OF THE TARSOCONJUNCTIVAL FLAP (FTC) IN PATIENTS WITH SEVERE OCULAR SURFACE IMPAIRMENT REFRACTORY TO PREVIOUS CONVENTIONAL TREATMENTS. BETWEEN 2015 TO 2019, A TOTAL OF EIGHT EYES OF 8 PATIENTS (5 MALES AND 3 FEMALES) WHERE PILLAR TARSOCONJUNCTIVAL FLAP (PTCF) WAS PERFORMED WERE INCLUDED IN THE STUDY. THREE PATIENTS HAD NEUROTROPHIC CORNEAL ULCER (NCU), THREE HAD EXPOSURE KERATOPATHY AND TWO HAD CORNEAL MELTING. DURING THE SURGERY, A DOUBLE-NEEDLED SUTURE (VICRYL 6/0 OR 5/0) IS PLACED IN THE CORNERS OF THE FLAP AND PASSED THROUGH A 1 × 2 MM EXCISED TARSOCONJUNCTIVAL POCKET IN THE LOWER EYELID, 2 MM APART FROM THE EDGE AS WELL, AND EXTERNALIZED TO THE SKIN SIDE OF THE EYELID 4 MM BENEATH THE EYELASH LINE, WHERE IT IS TIED OVER A SILICONE TUBE, THUS AVOIDING SKIN DAMAGE. THIS SUTURE CAN BE RELEASED AFTER TEN DAYS IF IT DOES NOT SPONTANEOUSLY BREAK. AS AN ALTERNATIVE, THE FLAP MAY BE ALSO SUTURED AT THE LEVEL OF THE INFERIOR FORNIX IN A SMALL POCKET MADE IN THE CONJUNCTIVA BELOW THE INFERIOR TARSUS. REPORTED COMPLICATIONS INCLUDE THE FOLLOWING: A 36-YEAR-OLD MALE (N=1) - PARTIAL DEHISCENCE OF THE SUTURE, FOR WHICH THE PATIENT HAD TO BE REOPERATED IN CONCLUSION, THIS STUDY SUGGEST PTCF IS A VALID ALTERNATIVE TO TARSORRHAPHY IN CASES OF PERSISTENT EPITHELIAL DEFECT (PED) OR NCU RESISTANT TO CONVENTIONAL TREATMENTS. NOTWITHSTANDING, PROSPECTIVE COMPARATIVE TRIALS COMPARING PTFC WITH CONVENTIONAL AND/OR NOVEL THERAPIES IN PED OR NCU ARE NEEDED TO CORROBORATE THESE FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1445348 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male Required Intervention