BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 12640307 · Received October 15, 2021

    Report

    Report Number
    2210968-2021-09758
    Event Type
    Injury
    Date Received
    October 15, 2021
    Report Date
    December 2, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. 1. WHAT WAS THE DATE OF INDEX SURGICAL PROCEDURE? 2. WHAT WERE THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? 3. PLEASE PROVIDE ANY RELEVANT PATIENT HISTORY: PATIENT PRE-EXISTING MEDICAL CONDITIONS (I.E. ALLERGIES, HISTORY OF REACTIONS), ALL CONCOMITANT MEDICATIONS, PAST MEDICAL HISTORY, ANY TREATMENT REQUIRED FOR EVENTS, DOSE, FREQUENCY, AND THERAPY DATES. 4. WAS THERE ANY INTRAOPERATIVE CONCURRENT USE OF OTHER PRODUCTS? 5. WHAT ARE THE PRODUCT CODE AND LOT NUMBER? 6. WHAT WAS THE INTENDED USE OF THE SURGICEL? WAS IT USED TO ADDRESS ACTIVE BLEEDING OR USED PROPHYLACTICALLY? 7. WHERE WAS THE SURGICEL USED (ON WHAT TISSUE)? 8. HOW MUCH SURGICEL WAS USED DURING THE PROCEDURE? 9. WAS THE SURGICEL PRODUCT LEFT IN PLACE? 10. HAS ANY SURGICAL OR MEDICAL INTERVENTION BEEN PERFORMED? 11. WHAT IS PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? 12. WAS THERE AN ALLEGED DEFICIENCY OF THE SURGICEL THAT CONTRIBUTED TO THE PATIENT¿S POST-OPERATIVE COURSE? 13. WHAT IS THE PATIENT¿S CURRENT STATUS? 14. WHAT WAS THE DRUG THERAPY USED FOR THE PATIENT¿S POST OPERATIVE SYMPTOMS? 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THE SURGICEL WAS USED IN THE EPIDURAL SPACE DURING SURGERY PERFORMED ON (B)(6) 2020. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. DOES ETHICON HAVE YOUR PERMISSION TO CONTACT YOUR SURGEON, IN THE EVENT ETHICON WOULD LIKE TO CONTACT YOUR SURGEON FOR MORE CLINICAL INFORMATION TO BE USED FOR A PRODUCT QUALITY COMPLAINT INVESTIGATION? IF SO, PLEASE PROVIDE YOUR SURGEON¿S NAME, CONTACT INFORMATION AND SIGN RELEASE OF MEDICAL INFORMATION FORM ATTACHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HEMILAMINECTOMY PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. A SMALL PLEDGET OF ABSORBABLE HEMOSTAT WAS LEFT IN THE EPIDURAL SPACE AND CLOSED. IT WAS REPORTED THAT THERE WAS NO ISSUE WITH THE PRODUCT, BUT THE ISSUE IS WITH THE USE OF THE PRODUCT. THE PATIENT REPORTED THAT THE NEUROSURGEON FAILED TO COMPLY WITH THE MANUFACTURER¿S INSTRUCTIONS AND WARNINGS ON THE ABSORBABLE HEMOSTAT INSERT. THE FOLLOWING ADVERSE EVENTS WERE REPORTED: POSTLAMINECTOMY SYNDROME, LUMBOSACRAL RADICULOPATHY, ENTHESOPATHY LUMBAR SPINE/ SACROILIITIS, CHRONIC LOW BACK PAIN, LATERAL FEMORAL CUTANEOUS NEUROPATHY, ARACHNOIDITIS NEUROGENIC BLADDER, LOWER LIMB LENGTH DIFFERENCE, LOWER EXTREMITY NUMBNESS, SI (SACROILIAC) JOINT DYSFUNCTION, SPINAL ENTHESOPATHY, LUMBOSACRAL REGION (HCC), STENOSIS OF LATERAL RECESS OF LUMBAR SPINE. THE REPORTED TREATMENT WITH FOOT ORTHOSIS TO THE RIGHT EQUATING TO 1/4 INCH LIFT AND THE PATIENT WAS ADVISED TO MIX OVER-THE-COUNTER TOPICAL LIDOCAINE 4% WITH HER VOLTAREN GEL. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1539956 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention