BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROMATRIX

    MDR report key: 7832319 · Received August 30, 2018

    Report

    Report Number
    3005920706-2018-00012
    Event Type
    Injury
    Date Received
    August 30, 2018
    Date of Event
    July 31, 2018
    Report Date
    July 31, 2018
    Manufacturer
    ACELL, INC.
    Product Code
    KGN
    UDI-DI
    00386190001202
    PMA / PMN Number
    K153754
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW-UP REPORT FOR ADDITIONAL INFORMATION THAT WAS RECEIVED SUBSEQUENT TO THE INITIAL FILING. ACELL WAS NOTIFIED ON (B)(6) 2018 THAT THE PATIENT HAD BEEN ON A PROPHYLACTIC DOSE OF LOVENOX, A BLOOD THINNER, FOR ABOUT A MONTH PRIOR TO INITIAL PLACEMENT OF THE ACELL DEVICE. THE INITIAL MDR WAS SUBMITTED DUE TO THE REPORTED HEMATOMA THAT OCCURRED DURING THE INITIAL PLACEMENT OF THE ACELL DEVICE. DURING THE SURGERY MICROMATRIX WAS FOCUSED MAINLY ON THE EXPOSED AREAS: BONE, TENDON AND UNDERMINED AREAS; VERSAJET WAS ALSO USED ON THE WOUND. THE PATIENT HAS AN EXTERNAL FIXTURE DEVICE ON HIS LEG AND ONGOING WOUND VAC THERAPY. ACELL HAS CONDUCTED TESTING ON THE CLOTTING CAPABILITIES OF ACELL MATERIALS, INCLUDING MICROMATRIX IN BOTH IN VITRO AND IN VIVO MODELS. IN BOTH MODELS, THE USE OF MICROMATRIX SHORTENED CLOTTING TIMES COMPARED TO THE CONTROLS, INDICATING A HEMOSTATIC EFFECT. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT IDENTIFIED NO DEVIATIONS IN THE PRODUCTION PROCESS THAT FALL OUTSIDE OF SPECIFICATION. THE DEVICE WAS MANUFACTURED AND DISTRIBUTED STERILE IN COMPLIANCE WITH FDA, STATE AND LOCAL LAWS AND REGULATIONS AND ACELL'S OPERATING PROCEDURES.

    Description of Event or Problem · 0

    ON (B)(4) 2018, ACELL, INC. BECAME AWARE A PATIENT EXPERIENCED HEMATOMA FORMATION AFTER APPLICATION OF ACELL DEVICES ON (B)(6) 2018 FOR AN ACUTE WOUND. THE PATIENT WAS IN A MOTORCYCLE ACCIDENT ABOUT 4 WEEKS EARLIER WHERE HE INCURRED A LARGE DE-GLOVING INJURY WITH EXPOSED BONE AND TENDON ON HIS LEFT LEG. WOUND VAC HAD BEEN UTILIZED FOR SEVERAL WEEKS PRIOR TO THE SURGERY ON (B)(6) 2018. DURING THE SURGERY ACELL MICROMATRIX WAS FOCUSED MAINLY ON THE EXPOSED AREAS: BONE, TENDON AND UNDERMINED AREAS; VERSAJET WAS ALSO USED ON THE WOUND. THE PATIENT HAS AN EXTERNAL FIXTURE DEVICE ON HIS LEG AND ONGOING WOUND VAC THERAPY.

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED DUE TO THE REPORTED HEMATOMA THAT OCCURRED DURING THE INITIAL PLACEMENT OF THE ACELL DEVICE. DURING THE SURGERY MICROMATRIX WAS FOCUSED MAINLY ON THE EXPOSED AREAS: BONE, TENDON AND UNDERMINED AREAS; VERSAJET WAS ALSO USED ON THE WOUND. THE PATIENT HAS AN EXTERNAL FIXTURE DEVICE ON HIS LEG AND ONGOING WOUND VAC THERAPY. ACELL HAS CONDUCTED TESTING ON THE CLOTTING CAPABILITIES OF ACELL MATERIALS, INCLUDING MICROMATRIX IN BOTH IN VITRO AND IN VIVO MODELS. IN BOTH MODELS, THE USE OF MICROMATRIX SHORTENED CLOTTING TIMES COMPARED TO THE CONTROLS, INDICATING A HEMOSTATIC EFFECT. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT IDENTIFIED NO DEVIATIONS IN THE PRODUCTION PROCESS THAT FALL OUTSIDE OF SPECIFICATION. THE DEVICE WAS MANUFACTURED AND DISTRIBUTED STERILE IN COMPLIANCE WITH FDA, STATE AND LOCAL LAWS AND REGULATIONS AND ACELL'S OPERATING PROCEDURES.

    Description of Event or Problem · 1

    ON (B)(6) 2018, ACELL, INC. BECAME AWARE A PATIENT EXPERIENCED HEMATOMA FORMATION AFTER APPLICATION OF ACELL DEVICES ON (B)(6) 2018 FOR AN ACUTE WOUND. THE PATIENT WAS IN A MOTORCYCLE ACCIDENT ABOUT 4 WEEKS EARLIER WHERE HE INCURRED A LARGE DE-GLOVING INJURY WITH EXPOSED BONE AND TENDON ON HIS LEFT LEG. WOUND VAC HAD BEEN UTILIZED FOR SEVERAL WEEKS PRIOR TO THE SURGERY ON (B)(6) 2018. DURING THE SURGERY MICROMATRIX WAS FOCUSED MAINLY ON THE EXPOSED AREAS: BONE, TENDON AND UNDERMINED AREAS; VERSAJET WAS ALSO USED ON THE WOUND. THE PATIENT HAS AN EXTERNAL FIXTURE DEVICE ON HIS LEG AND ONGOING WOUND VAC THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674498 MICROMATRIX MICROMATRIX KGN ACELL, INC. MM1000 012072 00386190001202

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention EXTERNAL FIXTURE DEVICE| LOVENOX| VERSAJET HYDROSURGERY SYSTEM| VERSAJET HYDROSURGERY SYSTEM| WOUND VAC THERAPY| WOUND VAC THERAPY| EXTERNAL FIXTURE DEVICE| VERSAJET HYDROSURGERY SYSTEM| WOUND VAC THERAPY