BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVAGEN

    MDR report key: 7830378 · Received August 29, 2018

    Report

    Report Number
    1000526113-2018-70004
    Event Type
    Malfunction
    Date Received
    August 29, 2018
    Date of Event
    August 2, 2018
    Report Date
    October 4, 2018
    Manufacturer
    RUSPAK CORPORATION
    Product Code
    KOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THIS NON-SERIOUS SPONTANEOUS MEDICAL DEVICE COMPLAINT REPORT FROM A CUSTOMER (US) WAS RECEIVED BY (B)(4) (DISTRIBUTOR) ON 06-AUG-2018. THIS CUSTOMER COMPLAINT WAS FORWARDED TO BELCHER PHARMACEUTICALS (PRODUCT HOLDER) ON 07-AUG-2018. INFORMATION HAS BEEN RECEIVED FROM A CONSUMER CONCERNING A 52-YEAR-OLD PATIENT WHO WAS USING NUVAGEN COLLAGEN POWDER. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATION INFORMATION WAS NOT PROVIDED. ON AN UNSPECIFIED DATE THE PATIENT STARTED TO USE NUVAGEN COLLAGEN POWDER (1 GM PACKET) FOR AN UNKNOWN INDICATION. LOT NUMBER WAS 170308A AND EXPIRY DATE WAS FEB-2022. THE PATIENT REPORTED USING NUVAGEN COLLAGEN POWDER FOR THREE DAYS AND CHANGED IT DAILY. ON (B)(6) 2018, DURING THE INITIAL APPLICATION, THE PATIENT NOTED BURNING SENSATION. IT WAS REPORTED THAT THE SENSATION WORSENED THE LONGER IT WAS ON. BURNING SENSATION WAS INTENSE ENOUGH TO PREVENT THE PATIENT FROM SLEEPING. NO OTHER SIDE EFFECTS WERE NOTED. THERE WAS NO REPORT OF RASH OR ITCHING OR HIVES OR SHORTNESS OF BREATH OR TACHYCARDIA. THE PHYSICIAN ORDERED VITAMIN E. COMPLAINT SAMPLE WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. CPN INITIATED THE PROCESS TO RETRIEVE THE REMAINING COLLAGEN POWDER BACK FROM THE PATIENT. THE OUTCOME OF THE EVENT WAS NOT REPORTED. THE CAUSALITY FOR THE EVENT 'BURNING SENSATION' WAS NOT REPORTED. FOLLOW UP INFORMATION WAS RECEIVED BY BELCHER PHARMACEUTICALS (PRODUCT HOLDER) ON 29-SEP-2018. THE COMPLAINT SAMPLE WAS RECALLED FROM THE PHYSICIAN'S OFFICE. VISUAL INSPECTION AND ANALYTICAL TESTING OF COMPLAINT SAMPLES WERE PERFORMED. ONE CARTON CONTAINED 15 POUCHES AND THE OTHER 12 POUCHES. TWO POUCHES FROM EACH CARTON WERE OPENED AND THE POWDER INSIDE WAS CHECKED FOR DESCRIPTION AND ODOUR. THE QUALITY OF COLLAGEN POWDER WAS FOUND TO BE GOOD, WITHIN SPECIFICATIONS, AND SATISFACTORY. THE QUALITY OF RETENTION SAMPLE POUCHES ARE ALSO VERIFIED AND FOUND TO BE WITHIN SPECIFICATIONS AND SATISFACTORY. A DETAILED INVESTIGATION WAS PERFORMED BY THE MANUFACTURER "RUSPAK CORPORATION" AT THEIR MANUFACTURING SITE WHERE DETAILED INSPECTION OF COLLAGEN POWDER MANUFACTURING PROCESS WAS PERFORMED. ALL THE MANUFACTURING PARAMETERS FOR THE COMPLAINT BATCH WERE FOUND TO BE WITHIN SPECIFICATIONS AND SATISFACTORY. THE COMPLAINT BATCH WAS PRODUCED WITH THE QC SPECIFICATIONS AND "RUSPAK STANDARD OPERATING PROCEDURES" WITHOUT ANY ANOMALIES. AN INVESTIGATION AT E-BEAM SERVICES AT THEIR SITE HAD NO EVIDENCE OF ANY QUALITY ISSUES FOR THE COMPLAINT BATCH (170308A) WAS REPORTED DURING IRRADIATION PROCESS. AS PER THE CERTIFICATE OF IRRADIATION FOR THE COMPLAINT BATCH, ALL THE DATA ARE WITHIN SPECIFICATIONS. THE PHYSICIAN DID NOT KEEP MEDICAL RECORD OF THE CONCERNED PATIENT FOR THE EVENT OR ANY NOTES POST THE EVENT. IT WAS UNKNOWN IF THE PATIENT ADVERSE REACTION WAS RESOLVED OR NOT. AFTER MULTIPLE ATTEMPTS, IT WAS NOT POSSIBLE TO GET ANY INFORMATION ABOUT THE PATIENT ADVERSE REACTION STATUS. THE COMPLAINT WAS CONSIDERED AS CLOSED AS THERE WAS NO ADDITIONAL INFORMATION ABOUT THE PATIENT. CASE COMMENT: THE EVENT APPLICATION SITE BURNING IS ASSESSED AS NON-SERIOUS AND POSSIBLY RELATED TO NUVAGEN COLLAGEN POWDER BASED ON THE TEMPORAL RELATIONSHIP AND SPONTANEOUS NATURE OF THE REPORT. THE EVENT IS UNLISTED AS PER THE PRODUCT LABEL. CASE COMMENT FOR FOLLOW UP INFORMATION RECEIVED ON 21-AUG-2018. FOLLOW-UP INFORMATION DOES NOT ALTER THE MEDICAL ASSESSMENT OF THIS CASE.

    Description of Event or Problem · 1

    THIS NON-SERIOUS SPONTANEOUS MEDICAL DEVICE COMPLAINT REPORT FROM A CUSTOMER (US) WAS RECEIVED BY (B)(4) (DISTRIBUTOR) ON (B)(6) 2018. THIS CUSTOMER COMPLAINT WAS FORWARDED TO (B)(4) (PRODUCT HOLDER) ON (B)(6) 2018. INFORMATION HAS BEEN RECEIVED FROM A CONSUMER CONCERNING A (B)(6)-YEAR-OLD PATIENT WHO WAS USING NUVAGEN COLLAGEN POWDER. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATION INFORMATION WAS NOT PROVIDED. ON AN UNSPECIFIED DATE THE PATIENT STARTED TO USE NUVAGEN COLLAGEN POWDER (1 GM PACKET) FOR AN UNKNOWN INDICATION. LOT NUMBER WAS 170308A AND EXPIRY DATE WAS FEB-2022. THE PATIENT REPORTED USING NUVAGEN COLLAGEN POWDER FOR THREE DAYS AND CHANGED IT DAILY. ON (B)(6) 2018, DURING THE INITIAL APPLICATION, THE PATIENT NOTED BURNING SENSATION. IT WAS REPORTED THAT THE SENSATION WORSENED THE LONGER IT WAS ON. BURNING SENSATION WAS INTENSE ENOUGH TO PREVENT THE PATIENT FROM SLEEPING. NO OTHER SIDE EFFECTS WERE NOTED. THERE WAS NO REPORT OF RASH OR ITCHING OR HIVES OR SHORTNESS OF BREATH OR TACHYCARDIA. THE PHYSICIAN ORDERED VITAMIN E. COMPLAINT SAMPLE WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. (B)(4) INITIATED THE PROCESS TO RETRIEVE THE REMAINING COLLAGEN POWDER BACK FROM THE PATIENT. THE OUTCOME OF THE EVENT WAS NOT REPORTED. THE CAUSALITY FOR THE EVENT 'BURNING SENSATION' WAS NOT REPORTED. CASE COMMENTS: THE EVENT APPLICATION SITE BURNING IS ASSESSED AS NON-SERIOUS AND POSSIBLY RELATED TO NUVAGEN COLLAGEN POWDER BASED ON THE TEMPORAL RELATIONSHIP AND SPONTANEOUS NATURE OF THE REPORT. THE EVENT IS UNLISTED AS PER THE PRODUCT LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666612 NUVAGEN NUVAGEN KOZ RUSPAK CORPORATION 170308A

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention