BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROKERA

    MDR report key: 9077737 · Received September 17, 2019

    Report

    Report Number
    3003415347-2019-00001
    Event Type
    Injury
    Date Received
    September 17, 2019
    Date of Event
    July 27, 2019
    Report Date
    September 12, 2019
    Manufacturer
    TISSUE TECH, INC.
    Product Code
    NQB
    PMA / PMN Number
    K032104
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: OTHER SERIOUS EVENT WAS SELECTED BASED ON INSTRUCTIONS FROM THE FDA 3500A SUPPLEMENT WHICH STATED FOR MEDICAL DEVICE, WHEN NONE OF THE OTHER OPTIONS APPLIED, SELECT OTHER SERIOUS EVENT. HOWEVER, THIS EVENT DOES NOT MEET THE SERIOUS ADVERSE EVENT DESCRIPTION. THIS REPORT IS BEING SUBMITTED IN RESPONSE TO THE MEDWATCH REPORT MW5088720 RECEIVED FROM THE FDA AND INITIATED BY THE PATIENT 02-AUG-2019.

    Description of Event or Problem · 1

    TISSUETECH, INC. RECEIVED A MEDWATCH REPORT MW5088720, SUBMITTED TO THE FDA BY A PATIENT IN WHICH THEY DESCRIBE GETTING TREATED FOR A RECURRENT CORNEAL ABRASION WITH A PROKERA SLIM ON (B)(6) 2019. THE MORNING AFTER GETTING THE PROKERA INSERTED INTO THEIR EYE, THE PATIENT REPORTED THEIR EYE HAD SWOLLEN SHUT, WAS MATTED AND RED. OTHER SIDE EFFECTS THAT THEY LISTED WERE SWELLING AND PAIN OF THE EYE SOCKET AND CHEEK BONE, LIGHT SENSITIVITY, COLD CHILLS AND DRY HEAVING. ON (B)(6), THE PATIENT HAD THE PROKERA REMOVED BY THEIR PHYSICIAN AND FELT INSTANT RELIEF. THREE DAYS AFTER GETTING THE PROKERA REMOVED THE PATIENT DESCRIBED ONLY HAVING SOME REDNESS AND SOME EYE DRYNESS. DR. (B)(6) (TISSUETECH, INC. MEDICAL DIRECTOR) CONTACTED DR. (B)(6) (UTILIZING PHYSICIAN) VIA PHONE ON (B)(6) 2019 AND PROVIDED THE FOLLOWING INFORMATION, "I HAVE SPOKEN TO DR. (B)(6) ON (B)(6) 2019 AND OBTAINED THE FOLLOWING MEDICAL INFORMATION. DR. (B)(6) HAS USED PROKERA SLIM (PKS) FOR A NUMBER OF PATIENTS INCLUDING THOSE WHO SUFFER FROM RECURRENT CORNEAL EROSION WITH A GREAT SUCCESS. IN THIS PARTICULAR CASE, WHO ALSO SUFFERED FROM RECURRENT CORNEAL EROSION, HE USED THE SAME TREATMENT REGIMEN, I.E., EPITHELIAL DEBRIDEMENT FOLLOWED BY INSERTION OF PKS AND TOPICAL PROPHYLACTIC ANTIBIOTICS. FURTHER INQUIRY DISCLOSED THAT THE PATIENT ALSO HAD FLOPPY EYELIDS, WHICH ARE KNOWN TO BE FREQUENTLY ASSOCIATED WITH RECURRENT CORNEAL EROSION. I HAVE EXPLAINED TO DR. (B)(6) THAT FLOPPY EYELID PATIENTS ARE KNOWN TO GENERATE EXCESSIVE INFLAMMATION EVEN WITH MINOR TRAUMA, I.E., EPITHELIAL DEBRIDEMENT OR INSTILLATION OF PRESERVATIVE-CONTAINING MEDICATION. I ALSO ASKED WHETHER THE PKS WAS CENTERED WELL AS IT IS OFTEN TIMES CHALLENGING TO ACHIEVE GOOD CENTRATION BECAUSE OF THE FLOPPY UPPER LID. HE DISCLOSED THAT AFTER REMOVAL OF PKS IN TWO DAYS AFTER INSERTION, THE PATIENT NOT ONLY RETURNED TO A NORMAL STATE BUT ALSO SHOWED NOTABLE IMPROVEMENT WHEN COMPARED TO THE TIME BEFORE INSERTION. CONSEQUENTLY, BOTH THE PATIENT AND DR. (B)(6) WERE PLEASED WITH THE OUTCOME. TAKING THAT OPPORTUNITY, I AS THE MEDICAL DIRECTOR AND AN OPHTHALMOLOGIST SPECIALIZED IN OCULAR SURFACE DISEASES FURTHER PROVIDED THE FOLLOWING ADVICES TO MITIGATE SIMILAR ADVERSE EVENT: CONSIDER ADDING PRESERVATIVE-FREE STEROID TO REDUCE THE EXCESSIVE INFLAMMATION THAT IS KNOWN TO BE GENERATED IN THIS SETTING AND ADD TAPE TARSORRHAPHY TO IMMOBILIZE THE UPPER LID SO THAT THE LID SWELLING DUE TO BLINKING CAN BE AVOIDED." THE SYMPTOMS THAT THE PATIENT EXPERIENCED CAN BE ATTRIBUTED PARTLY TO THEIR PRE-EXISTING CONDITION AND PARTLY TO OUR PRODUCT. THE FIRST EVENT THAT CAUSED THE PAIN AND INFLAMMATION THE PATIENT EXPERIENCED WAS THE EPITHELIAL DEBRIDEMENT THAT THE PHYSICIAN PERFORMED. THIS IS THE SAME PROCEDURE THAT THE PHYSICIAN HAS PERFORMED FOR OTHER PATIENTS DIAGNOSED WITH RECURRENT CORNEAL EROSION (RCE) FOLLOWED BY THE INSERTION OF A PKS. THIS PATIENT, HOWEVER, ALSO HAD FLOPPY EYELIDS AS DESCRIBED BY THE PHYSICIAN. PATIENTS WITH THIS CONDITION ARE MORE SUSCEPTIBLE TO EXPERIENCE EYE SWELLING, ESPECIALLY AFTER A PROCEDURE SUCH AS EPITHELIAL DEBRIDEMENT. THE NEXT EVENT THAT MAY HAVE ATTRIBUTED TO THE PAIN AND SWELLING THAT THE PATIENT EXPERIENCED WAS THE INSERTION OF THE PKS. SINCE THIS PATIENT HAD FLOPPY EYELIDS, THE PROCESS OF INSERTING THE PKS AND KEEPING IT CENTERED WOULD HAVE BEEN MORE CHALLENGING FOR THE PHYSICIAN. IN THIS CASE, TAPE TARSORRHAPHY WAS NOT PERFORMED BY THE PHYSICIAN, WHICH IS RECOMMENDED IN THE PRODUCT INSERT FOR ALL PROKERA PATIENTS. THIS PRACTICE IS USED TO AVOID LID SWELLING DUE TO EXCESSIVE BLINKING AND EXPOSURE OF THE DEVICE. THE FACT THAT TAPE TARSORRHAPHY WAS NOT PERFORMED BY THE PHYSICIAN, ALSO COULD HAVE CAUSED EXCESSIVE INFLAMMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869031 PROKERA PROKERA SLIM NQB TISSUE TECH, INC. PKS TGVK19A017

    Patients

    Seq Age Sex Outcome Treatment
    1 Other