BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHILON NYLON SUTURE UNKNOWN PRODUCT

    MDR report key: 11711071 · Received April 22, 2021

    Report

    Report Number
    2210968-2021-03666
    Event Type
    Injury
    Date Received
    April 22, 2021
    Date of Event
    January 1, 2016
    Report Date
    April 14, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 05/06/2021. ADDITIONAL INFORMATION: B3, B7 . ADDITIONAL B5 NARRATIVE: IT WAS REPORTED THAT A RHINOPLASTY WAS PERFORMED ON (B)(6) 2003. A STANDARD SEPTOPLASTY WAS PERFORMED VIA A HEMITRANSFIXION TO ADDRESS THE DEVIATED SEPTUM. THE SOFT-SKIN TISSUE ENVELOPE WAS RE-DRAPED AND THE INCISION CLOSED WITH 6-0 NYLON SUTURES INTRANASALLY. THE PATIENT TOLERATED THE PROCEDURE WELL AND HAD NO COMPLICATIONS. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: PLEASE CLARIFY THE YEAR OF RHINOPLASTY SURGERY (IT WAS REPORTED AS (B)(6) 2021). DOES ETHICON HAVE YOUR PERMISSION TO CONTACT YOUR SURGEON/HEALTH CARE PROFESSIONAL, IN THE EVENT ETHICON WOULD LIKE TO CONTACT YOUR SURGEON/HEALTH CARE PROFESSIONAL FOR MORE CLINICAL INFORMATION TO BE USED FOR A PRODUCT QUALITY COMPLAINT INVESTIGATION? IF SO, PLEASE PROVIDE YOUR DOCTOR/SURGEON¿S NAME, CONTACT INFORMATION INCLUDING EMAIL ADDRESS AND PHONE NUMBER IF POSSIBLE. I HAD SURGERY IN (B)(6) 2003. THE SURGEON THAT PERFORMED THE SURGERY RETIRED SEVERAL YEARS AGO, BUT FORTUNATELY I WAS ABLE TO SPEAK WITH HIM EARLIER THIS YEAR AND HE ADVISED THAT NYLON ETHICON STITCHES WERE USED AND WERE NOT REMOVED, BUT ARE NOT LISTED ON THE OPS REPORT. I HAVE HAD ALLERGIES SINCE I WAS A KID TO DIFFERENT MATERIALS, ETC. SO I BELIEVE THIS IS CAUSING THE ISSUE. 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 Manufacturer Narrative · 1

    PRODUCT COMPLAINT: (B)(4). ATTEMPTS ARE BEING MADE TO CLARIFY 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. IF IN YOUR POSSESSION, MAY WE HAVE COPIES OF YOUR OPERATIVE REPORT, AND EXAMINATION REPORTS? PLEASE CLARIFY THE YEAR OF RHINOPLASTY SURGERY (IT WAS REPORTED AS (B)(6) 2021). DOES ETHICON HAVE YOUR PERMISSION TO CONTACT YOUR SURGEON/HEALTH CARE PROFESSIONAL, IN THE EVENT ETHICON WOULD LIKE TO CONTACT YOUR SURGEON/HEALTH CARE PROFESSIONAL FOR MORE CLINICAL INFORMATION TO BE USED FOR A PRODUCT QUALITY COMPLAINT INVESTIGATION? IF SO, PLEASE PROVIDE YOUR DOCTOR/SURGEON¿S NAME, CONTACT INFORMATION INCLUDING EMAIL ADDRESS AND PHONE NUMBER IF POSSIBLE. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: CAN YOU IDENTIFY THE PRODUCT CODE AND LOT NUMBER OF THE PRODUCT THAT WAS USED? THE DOCTOR DID NOT PROVIDE THIS BUT ADVISED ETHICON WAS USED. HOW WAS ITCHING AND BURNING MANAGED? ANY MEDICAL TREATMENT PROVIDED OR PRESCRIBED? IF YES, PLEASE PROVIDE MEDICINE NAME, STRENGTH, AND DOSE: PREDNISONE (MEDIUM DOSAGE) WAS USED FOR A WEEK BUT THE SIDE EFFECTS WERE AWFUL AND NO DECREASE IN SYMPTOMS. BENADRYL CREAM WAS USED FOR MONTHS, BUT I WAS ADVISED BY MEDICAL PROFESSIONALS THAT THE CREAM COULD RESTRICT BLOOD VESSELS LIMITING BLOOD SUPPLY TO THE GRAFTS. SO THIS WAS DISCONTINUED. CROMOLYN- ORAL DOSAGE. THIS DID NOT STOP SYMPTOMS. MANY PRESCRIPTION NASAL SPRAYS (NASACORT/FLONASE) WERE USED, AND THOUGH IT GAVE TEMPORARY RELIEF, THE PAIN/BURNING WAS WORSE AFTER DISCONTINUATION. I WAS ADVISED THAT THESE SHOULD NOT BE USED LONG-TERM DUE TO GRAFTS/BLOOD VESSEL RESTRICTIONS. ALLERGY SHOTS ¿ TRIED FOR A FEW MONTHS AT THE ALLERGISTS PLEADING WHEN I DIDN¿T KNOW I HAD A FOREIGN BODY IN MY NOSE. CLARITIN AND ZYRTEC ¿ WHILE I RECEIVED TEMPORARY RELIEF ON THE DOSAGE, MY NOSE BECAME DRIER AND ITCHED/BURNED WORSE AFTER USE. THESE MEDS ARE BLOOD VESSEL CONSTRICTORS AND CAN NOT BE USED WITH NOSES THAT HAVE GRAFTS (MY OWN SEPTAL CARTILAGE TISSUE) AND NEED NO REDUCTION IN BLOOD FLOW. RECEIVED MRA AND MRI OF MY NOSE TO SEE IF ANYTHING LOOKED ABNORMAL BEFORE IT WAS CONFIRMED BY THE SURGEON THAT ETHICON NYLON STITCHES WERE IN MY NOSE PERMANENTLY. WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION STEROIDS; ANTIBIOTICS PRESCRIBED, PRESCRIPTION MEDICINE)? IF SO, PLEASE CLARIFY. NO SURGERY HAS BEEN DONE. MY NOSE IS VERY SMALL DUE TO RESORPTION. NEED TO FIND OUT IF THE STITCHES WOULD BE INTACT TO PULL OUT WITHOUT DESTROYING MY NOSE AND WOULD THEY EVEN BE DISCERNABLE. I JUST CONFIRMED THIS YEAR THAT I HAVE THE NYLON STITCHES AT THEY WEREN¿T LISTED IN THE OPS REPORT. WHAT DOES THE REACTION LOOK LIKE AND HOW LARGE OF AN AREA DOES THE REACTION COVER? - MY ENTIRE NOSE. MY NOSE IS PINK AT TIMES, BUT IT IS ALWAYS BURNING AND ITCHING. COULD YOU PLEASE PROVIDE THE INITIAL PROCEDURE DATE? - (B)(6) 2021. WHAT DATE DID THE REACTION OCCURRED ON? - NOSE STARTED RESORBING RIGHT AFTER SURGERY AND HAS CONTINUED BUT THE ITCHING AND BURNING STARTED PROBABLY 5 YEARS AGO. THE RESORPTION RATE HAS DIRECTLY INCREASED WITH THE INTENSITY OF THE ITCHING/BURNING. WAS THERE ANY ALLEGED DEFICIENCY WITH THE DEVICE AS A CONTRIBUTING FACTOR AS MENTIONED IN THE EVENT DESCRIPTION? - NO THAT WE ARE AWARE. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WHAT IS THE MOST CURRENT PATIENT STATUS? IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THE PATIENT UNDERWENT A RHINOPLASTY ON (B)(6) SEVERAL YEARS AGO AND THE SUTURE WAS USED. THE PATIENT REPORTED THAT HER NOSE STARTED RESORBING RIGHT AFTER INITIAL SURGERY AND HAS CONTINUED BUT THE ITCHING AND BURNING STARTED PROBABLY 5 YEARS AGO. THE RESORPTION RATE HAS DIRECTLY INCREASED WITH THE INTENSITY OF THE ITCHING/BURNING. THE PATIENT HAS BEEN EXPERIENCING ITCHING AND BURNING IN HER NOSE FOR THE LAST FIVE TO SEVEN YEARS. IT WAS REPORTED THAT THE PATIENT WAS GIVEN A MEDIUM DOSAGE OF PREDNISONE FOR A WEEK, BUT SHE HAD SIDE EFFECTS AND NO DECREASE IN SYMPTOMS. BENADRYL CREAM WAS USED FOR MONTHS, BUT IT WAS DISCONTINUED AS ADVISED BY MEDICAL PROFESSIONALS THAT THE CREAM COULD RESTRICT BLOOD VESSELS LIMITING BLOOD SUPPLY TO THE GRAFTS. SYMPTOMS WERE NOT STOPPED BY ORAL DOSAGE OF CROMOLYN. MANY PRESCRIPTIONS OF NASAL SPRAYS SUCH AS NASACORT/FLONASE WERE USED, AND THOUGH IT GAVE TEMPORARY RELIEF, THE PAIN/BURNING WAS WORSE AFTER DISCONTINUATION. THE PATIENT WAS ADVISED THAT THESE SHOULD NOT BE USED LONG-TERM DUE TO GRAFTS/BLOOD VESSEL RESTRICTIONS. IT WAS REPORTED THAT THE PATIENT TRIED ALLERGY SHOTS FOR A FEW MONTHS AT THE ALLERGISTS PLEADING WHEN SHE DIDN¿T KNOW SHE HAD A FOREIGN BODY IN THE NOSE. THE PATIENT ALSO WAS TAKEN CLARITIN AND ZYRTEC BUT WHILE SHE RECEIVED TEMPORARY RELIEF ON THE DOSAGE, HER NOSE BECAME DRIER AND ITCHED/BURNED WORSE AFTER USE. THE PATIENT RECEIVED MRA AND MRI OF THE NOSE TO SEE IF ANYTHING LOOKED ABNORMAL BEFORE IT WAS CONFIRMED BY THE SURGEON THAT STITCHES WERE IN HER NOSE PERMANENTLY. THERE WAS NO SURGICAL INTERVENTION HAS BEEN DONE. AS PER PATIENT, THE NOSE IS VERY SMALL DUE TO RESORPTION. SHE HAS NO CURRENT PLANS FOR FURTHER MEDICAL TREATMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606846 ETHILON NYLON SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAR ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT