BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVAGEN

    MDR report key: 7042070 · Received November 17, 2017

    Report

    Report Number
    1000526113-2017-70002
    Event Type
    Malfunction
    Date Received
    November 17, 2017
    Date of Event
    September 14, 2017
    Report Date
    December 22, 2017
    Manufacturer
    RUSPAK CORPORATION
    Product Code
    KOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS NON-SERIOUS SPONTANEOUS MEDICAL DEVICE COMPLAINT REPORT FROM A CUSTOMER (US) WAS RECEIVED BY (B)(4) (DISTRIBUTOR) ON 15-SEP-2017. THIS CUSTOMER COMPLAINT WAS FORWARDED TO BELCHER PHARMACEUTICALS (PRODUCT HOLDER) ON 18-OCT-2017. INFORMATION HAS BEEN RECEIVED FROM A CONSUMER CONCERNING A FEMALE PATIENT OF UNSPECIFIED AGE WHO WAS USING NUVAGEN COLLAGEN POWDER. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATION INFORMATION WAS NOT PROVIDED. FROM AN UNSPECIFIED DATE THE PATIENT WAS USING NUVAGEN COLLAGEN POWDER (1 GM PACKET). BATCH NUMBER AND EXPIRY DATE WAS NOT PROVIDED. ON 14-SEP-2017, WHILE APPLYING NUVAGEN COLLAGEN POWDER, THE PATIENT EXPERIENCED PAIN AT WOUND SITE. IT WAS REPORTED THAT THE PATIENT HAD WOUNDS BETWEEN HER TOES AND THE WOUNDS WERE SEVERE. WHEN THE CONSUMER APPLIED COLLAGEN POWDER TO HER MOTHER'S WOUNDS, THE PATIENT COULD NOT TOLERATE AS SHE HAD PAIN AT WOUND SITE. THE PATIENT RECEIVED ALGINATE WITH SILVER PER ORDER FROM DOCTOR. THE PATIENT'S PAIN WAS RESOLVED. THE REPORTER STATED THAT DUE TO THE SEVERITY OF THE WOUNDS, ANY DRESSING WOULD HAVE CAUSED THE PAIN AT THE WOUND SITE AND THAT IT WAS NOT ACTUALLY RELATED TO THE COLLAGEN POWDER ITSELF. FOLLOW UP INFORMATION WAS RECEIVED AT PAREXEL ON 28-NOV-2017. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FROM THE REPORTER. IT WAS FOUND AT MANUFACTURER'S SITE THAT THREE BATCHES ONLY, LOT # 150216, 150216A AND 150506 WERE MANUFACTURED AND DISTRIBUTED. THE RETENTION SAMPLE PACKAGES OF COLLAGEN POWDER PACKS WERE INSPECTED AND ALL THE PARAMETERS ARE WITHIN SPECIFICATIONS AND SATISFACTORY. IT WAS FOUND THAT COLLAGEN POWDER IS NOT THE SUITABLE AND CORRECT MEDICATION FOR THE PATIENT'S PROBLEM. A DETAILED INVESTIGATION WAS PERFORMED BY THE MANUFACTURER "RUSPAK CORPORATION" AT THEIR MANUFACTURING SITE AND ALSO AT "E. BEAM SERVICES, INC" WHERE THE PRODUCT COLLAGEN POWDER WAS IRRADIATED BY ELECTRON BEAM FOR STERILIZATION PURPOSES. AS PER THE MANUFACTURER'S INVESTIGATION, THE QUALITY OF COLLAGEN POWDER WAS FOUND TO BE GOOD AND SATISFACTORY. THERE WERE NO QUALITY RELATED PROBLEMS OBSERVED WITH THE MEDICAL DEVICE COLLAGEN POWDER. THE COMPLAINT WAS CLOSED. CASE COMMENT: THE EVENT APPLICATION SITE PAIN IS CONSIDERED AS NON-SERIOUS AND IS POSSIBLY RELATED TO NUVAGEN COLLAGEN POWDER BASED ON THE PLAUSIBLE TEMPORAL RELATIONSHIP AND THE SPONTANEOUS NATURE OF THE REPORT. HOWEVER, THE UNDERLYING WOUND COULD HAVE CONTRIBUTED TO THE EVENT. APPLICATION SITE PAIN IS UNLISTED AS PER THE CARTON LABEL PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS INITIAL NON-SERIOUS SPONTANEOUS REPORT, WHICH ORIGINATED FROM THE UNITED STATES, WAS RECEIVED ON 15-SEP-2017. INFORMATION HAS BEEN RECEIVED FROM A CONSUMER CONCERNING A FEMALE PATIENT ON UNSPECIFIED AGE WHO WAS USING NUVAGEN COLLAGEN POWDER. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATION INFORMATION WAS NOT PROVIDED. FROM AN UNSPECIFIED DATE THE PATIENT WAS USING NUVAGEN COLLAGEN POWDER (1 GM PACKET). BATCH NUMBER AND EXPIRY DATE WAS NOT PROVIDED. ON (B)(6) 2017, WHILE APPLYING NUVAGEN COLLAGEN POWDER, THE SUBJECT EXPERIENCED PAIN AT WOUND SITE. IT WAS REPORTED THAT THE PATIENT HAD WOUNDS BETWEEN HER TOES AND THE WOUNDS WERE SEVERE. WHEN THE CONSUMER APPLIED COLLAGEN POWDER TO HER MOTHER'S WOUNDS, THE PATIENT COULD NOT TOLERATE AS SHE HAD PAIN AT WOUND SITE. THE PATIENT RECEIVED ALGINATE WITH SILVER PER ORDER FROM DOCTOR. ACTION TAKEN WITH NUVAGEN COLLAGEN POWDER WAS NOT REPORTED. OUTCOME OF THE EVENT 'PAIN AT WOUND SITE' WAS NOT REPORTED. THE REPORTER STATED THAT DUE TO THE SEVERITY OF THE WOUNDS, ANY DRESSING WOULD HAVE CAUSED THE PAIN AT THE WOUND SITE AND THAT IT WAS NOT ACTUALLY RELATED TO THE COLLAGEN POWDER ITSELF. A PRODUCT QUALITY COMPLAINT WAS RAISED AND COMPLAINT SAMPLE WAS NOT AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THIS NON-SERIOUS SPONTANEOUS MEDICAL DEVICE COMPLAINT REPORT FROM A CUSTOMER (US) WAS RECEIVED BY (B)(4) ON (B)(6) 2017. THIS CUSTOMER COMPLAINT WAS FORWARDED TO BELCHER PHARMACEUTICALS (PRODUCT HOLDER) ON (B)(6) 2017. INFORMATION HAS BEEN RECEIVED FROM A CONSUMER CONCERNING A FEMALE PATIENT OF UNSPECIFIED AGE WHO WAS USING NUVAGEN COLLAGEN POWDER. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATION INFORMATION WAS NOT PROVIDED. FROM AN UNSPECIFIED DATE THE PATIENT WAS USING NUVAGEN COLLAGEN POWDER (1 GM PACKET). BATCH NUMBER AND EXPIRY DATE WAS NOT PROVIDED. ON (B)(6) 2017, WHILE APPLYING NUVAGEN COLLAGEN POWDER, THE PATIENT EXPERIENCED PAIN AT WOUND SITE. IT WAS REPORTED THAT THE PATIENT HAD WOUNDS BETWEEN HER TOES AND THE WOUNDS WERE SEVERE. WHEN THE CONSUMER APPLIED COLLAGEN POWDER TO HER MOTHER'S WOUNDS, THE PATIENT COULD NOT TOLERATE AS SHE HAD PAIN AT WOUND SITE. THE PATIENT RECEIVED ALGINATE WITH SILVER PER ORDER FROM DOCTOR. THE PATIENT'S PAIN WAS RESOLVED. THE REPORTER STATED THAT DUE TO THE SEVERITY OF THE WOUNDS, ANY DRESSING WOULD HAVE CAUSED THE PAIN AT THE WOUND SITE AND THAT IT WAS NOT ACTUALLY RELATED TO THE COLLAGEN POWDER ITSELF. FOLLOW UP INFORMATION WAS RECEIVED AT PAREXEL ON 28-NOV-2017. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FROM THE REPORTER. IT WAS FOUND AT MANUFACTURER'S SITE THAT THREE BATCHES ONLY, LOT # 150216, 150216A AND 150506 WERE MANUFACTURED AND DISTRIBUTED. THE RETENTION SAMPLE PACKAGES OF COLLAGEN POWDER PACKS WERE INSPECTED AND ALL THE PARAMETERS ARE WITHIN SPECIFICATIONS AND SATISFACTORY. IT WAS FOUND THAT COLLAGEN POWDER IS NOT THE SUITABLE AND CORRECT MEDICATION FOR THE PATIENT'S PROBLEM. A DETAILED INVESTIGATION WAS PERFORMED BY THE MANUFACTURER "RUSPAK CORPORATION" AT THEIR MANUFACTURING SITE AND ALSO AT "E. BEAM SERVICES, INC" WHERE THE PRODUCT COLLAGEN POWDER WAS IRRADIATED BY ELECTRON BEAM FOR STERILIZATION PURPOSES. AS PER THE MANUFACTURER'S INVESTIGATION, THE QUALITY OF COLLAGEN POWDER WAS FOUND TO BE GOOD AND SATISFACTORY. THERE WERE NO QUALITY RELATED PROBLEMS OBSERVED WITH THE MEDICAL DEVICE COLLAGEN POWDER. THE COMPLAINT WAS CLOSED. CASE COMMENT: THE EVENT APPLICATION SITE PAIN IS CONSIDERED AS NON-SERIOUS AND IS POSSIBLY RELATED TO NUVAGEN COLLAGEN POWDER BASED ON THE PLAUSIBLE TEMPORAL RELATIONSHIP AND THE SPONTANEOUS NATURE OF THE REPORT. HOWEVER, THE UNDERLYING WOUND COULD HAVE CONTRIBUTED TO THE EVENT. APPLICATION SITE PAIN IS UNLISTED AS PER THE CARTON LABEL PROVIDED.

    Description of Event or Problem · 1

    THIS INITIAL NON-SERIOUS SPONTANEOUS REPORT, WHICH ORIGINATED FROM THE UNITED STATES, WAS RECEIVED ON 15-SEP-2017. INFORMATION HAS BEEN RECEIVED FROM A CONSUMER CONCERNING A FEMALE PATIENT ON UNSPECIFIED AGE WHO WAS USING NUVAGEN COLLAGEN POWDER. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATION INFORMATION WAS NOT PROVIDED. FROM AN UNSPECIFIED DATE THE PATIENT WAS USING NUVAGEN COLLAGEN POWDER (1 GM PACKET). BATCH NUMBER AND EXPIRY DATE WAS NOT PROVIDED. ON (B)(6) 2017, WHILE APPLYING NUVAGEN COLLAGEN POWDER, THE SUBJECT EXPERIENCED PAIN AT WOUND SITE. IT WAS REPORTED THAT THE PATIENT HAD WOUNDS BETWEEN HER TOES AND THE WOUNDS WERE SEVERE. WHEN THE CONSUMER APPLIED COLLAGEN POWDER TO HER MOTHER'S WOUNDS, THE PATIENT COULD NOT TOLERATE AS SHE HAD PAIN AT WOUND SITE. THE PATIENT RECEIVED ALGINATE WITH SILVER PER ORDER FROM DOCTOR. ACTION TAKEN WITH NUVAGEN COLLAGEN POWDER WAS NOT REPORTED. OUTCOME OF THE EVENT 'PAIN AT WOUND SITE' WAS NOT REPORTED. THE REPORTER STATED THAT DUE TO THE SEVERITY OF THE WOUNDS, ANY DRESSING WOULD HAVE CAUSED THE PAIN AT THE WOUND SITE AND THAT IT WAS NOT ACTUALLY RELATED TO THE COLLAGEN POWDER ITSELF. A PRODUCT QUALITY COMPLAINT WAS RAISED AND COMPLAINT SAMPLE WAS NOT AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819245 NUVAGEN NUVAGEN KOZ RUSPAK CORPORATION 150216, 150216A AND 150506

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention