BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN PICO

    MDR report key: 10382568 · Received August 7, 2020

    Report

    Report Number
    8043484-2020-02341
    Event Type
    Injury
    Date Received
    August 7, 2020
    Report Date
    December 2, 2020
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    WE HAVE NOW CONCLUDED OUR INVESTIGATION FOR THE COMPLAINT RECEIVED. A REVIEW OF THE BATCH MANUFACTURING RECORDS COULD NOT BE PERFORMED AS NO PART OR LOT NUMBERS WERE PROVIDED, HOWEVER, THERE ARE NO INDICATIONS TO SUGGEST THAT THE DEVICE DID NOT MEET SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A COMPLAINT HISTORY REVIEW WAS CARRIED OUT ACROSS ALL PICO PRODUCTS. THERE HAVE BEEN FURTHER COMPLAINTS REPORTED WITH THIS FAILURE MODE IN THE PAST THREE YEARS. THE DEVICE WAS INTENDED FOR USE IN TREATMENT. AS NO SAMPLES WERE RETURNED, A PRODUCT EVALUATION COULD NOT BE CARRIED OUT. IT IS RECOMMENDED THAT DRESSINGS ARE CHANGED AROUND EVERY 3 DAYS BUT IN SOME CASES MAY BE LEFT IN PLACE FOR 7 DAYS. IF THE ADHESIVE INTEGRITY IS COMPROMISED DUE TO PROLONGED WEAR, THE SURGICAL SITE MAY BE SUSCEPTIBLE TO EXTERNAL CONTAMINATION. A CLINICAL INVESTIGATION CONCLUDED: THIS COMPLAINT FROM DENMARK WAS FROM THE LITERATURE ARTICLE ¿CLINICAL EVALUATION OF SCAR QUALITY FOLLOWING THE USE OF PROPHYLACTIC NEGATIVE PRESSURE WOUND THERAPY IN OBESE WOMEN UNDERGOING CESAREAN DELIVERY.¿ THE PURPOSE OF THE ARTICLE WAS TO EVALUATE THE COSMETIC RESULT OF USING INCISIONAL NEGATIVE-PRESSURE WOUND THERAPY (INPWT) COMPARED WITH STANDARD POSTSURGICAL DRESSINGS IN OBESE WOMEN UNDERGOING CESAREAN DELIVERY. IN THIS RANDOMIZED CONTROLLED TRIAL 876 WOMEN WITH A PRE-PREGNANCY BODY MASS INDEX (BMI) OF 30 KG/M2 OR GREATER WHO UNDERWENT AN EMERGENCY OR PLANNED CD. THE INPWT PICO DRESSING WAS LEFT IN SITU FOR APPROXIMATELY 5 DAYS AND THE STANDARD POSTOPERATIVE DRESSING FOR AT LEAST 24 HOURS. THE ARTICLE CONCLUDED THAT ¿PROPHYLACTIC INPWT HAS BEEN FOUND TO REDUCE THE RISK OF SURGICAL SITE INFECTION FOLLOWING CD¿ AND THAT THE WOMEN TREATED WITH AN INPWT DRESSING WAS MORE SATISFIED WITH THE OVERALL APPEARANCE WITH THE SCAR. THE PHOTOS PROVIDED VIA E-MAIL RESPONSE HAVE BEEN REVIEWED, HOWEVER IT WAS NOT RELATED TO THE REPORTED ¿WOUND DEHISCENCE.¿ IT WAS ALSO NOTED IN THE E-MAIL THAT THE MINOR WOUND DEHISCENCE WAS A SECONDARY OUTCOME ¿RELATED TO THE SURGICAL PROCEDURE AND NOT THE DEVICE.¿ WITHOUT CLINICALLY RELEVANT PATIENT-SPECIFIC SUPPORTING DOCUMENTATION, A THOROUGH MEDICAL INVESTIGATION CANNOT BE PERFORMED. THE ROOT CAUSE AND/OR PATIENT OUTCOME BEYOND THAT WHICH WAS DOCUMENTED IN THE ARTICLE CANNOT BE CONFIRMED NOR CONCLUDED; THEREFORE, NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. THE RISK FILES FOR PICO CONTAIN MULTIPLE FAILURE MODES LEADING TO WOUND DEHISCENCE CAUSED BY POOR TECHNIQUE OR TIMING OF DRESSING REMOVAL AND CHANGES. WITHOUT FURTHER INFORMATION, AN EXACT FAILURE MODE CANNOT BE DETERMINED. WE HAVE NOT BEEN ABLE TO CONFIRM A RELATIONSHIP BETWEEN THE EVENT AND THE DEVICE OR IDENTIFY A DEFINITIVE ROOT CAUSE. NO FURTHER ACTIONS BY SMITH AND NEPHEW ARE DEEMED NECESSARY AT THIS STAGE. HOWEVER, WE WILL CONTINUE TO MONITOR FOR ANY ADVERSE TRENDS RELATING TO THIS PRODUCT RANGE. SMITH AND NEPHEW ACKNOWLEDGE CUSTOMER CONCERN AND ARE CONTINUALLY INVESTIGATING WAYS TO DEVELOP AND IMPROVE OUR PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE PUBLICATION "CLINICAL EVALUATION OF SCAR QUALITY FOLLOWING THE USE OF PROPHYLACTIC NEGATIVE PRESSURE WOUND THERAPY IN OBESE WOMEN UNDERGOING CESAREAN DELIVERY" THAT THE AIM OF THE STUDY WAS TO EVALUATE THE COSMETIC RESULT OF USING INCISIONAL NEGATIVE-PRESSURE WOUND THERAPY (PICO; SMITH & NEPHEW MEDICAL LTD, UK) COMPARED WITH STANDARD POSTSURGICAL DRESSINGS IN OBESE WOMEN UNDERGOING CESAREAN DELIVERY (CD). IN THE PAPER IT IS STATED THAT A WOMEN PRESENTED A MINOR WOUND DEHISCENCE WHILE USING PICO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845167 UNKN PICO NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP SMITH & NEPHEW MEDICAL LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other