FDA Adverse Event Injury Summary report: N

MEPILEX BORDER AG

MDR report key: 4109180 · Received September 15, 2014

Report

Report Number
MW5038247
Event Type
Injury
Date Received
September 15, 2014
Date of Event
February 4, 2014
Report Date
September 15, 2014
Manufacturer
MOLNLYCKE HEALTH CARE US, LLC
Product Code
FRO
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

MY MOTHER WAS HOSPITALIZED AT (B)(6) HOSPITAL FOR BREATHING PROBLEMS AND WAS ADMITTED TO THE EMERGENCY ROOM IN (B)(6) 2014. ONE PROBLEM SHE HAD AT THE TIME, WAS VERY THIN SKIN AND SHE HAD SOME SKIN TEARS ON HER ARMS FROM BUMPING INTO THINGS. SHE IS (B)(6) AND HER SKIN ON HER ARMS IS LIKE TISSUE PAPER, IT IS SO THIN. HOWEVER, SHE DOES HAVE VERY GOOD HEALING QUALITIES AND NORMALLY WHEN SHE WOULD ACCIDENTLY GET A SKIN TEAR, WITH A SPRAY OF HYDROGEN PEROXIDE AND A LOOSE BANDAGE, THE SKIN WOULD SCAB OVER AND HEAL WITH NO INFECTION QUITE RAPIDLY. HOWEVER, WHEN SHE WAS AT THE HOSPITAL, THE NURSE, (B)(6), IN THE EMERGENCY ROOM INSISTED ON USING THE "MEPILEX" BANDAGE FOR HER SKIN TEARS, WHICH WERE NOT COMPRESSION SORES. THE BANDAGES STUCK TO MY MOTHER'S SKIN TEARS WHEN WE TRIED TO REMOVE THEM A COUPLE OF DAYS LATER. IT TOOK OUR HOME NURSE AID A GREAT DEAL OF TIME AND CARE AS SHE SLOWLY SOAKED THE BANDAGE, CAREFULLY DETACHING IT FROM MY MOTHERS OPEN FLESH. THIS TYPE OF BANDAGE IS EVIDENTLY FOR PRESSURE SORES AND WHEN I INSISTED TO THE NURSE THAT I DID NOT WANT THAT TYPE OF BANDAGE APPLIED TO MY MOTHER'S SKIN TEARS, SHE REFUSED TO RESPECT MY WISHES AND INSISTED THAT THIS IS WHAT SHE WAS INSTRUCTED TO ALWAYS USE AND SHE APPLIED THE "MEPILEX" ANYWAY. I BELIEVE IT SHOULD BE OF UTMOST IMPORTANCE TO EDUCATE HOSPITAL ADMINISTRATORS, SUPERVISORS, HEADS OF NURSING STAFF AND NURSES, THE DIFFERENCES IN BANDAGE USE WHEN IT COMES TO USING CERTAIN TYPES OF BANDAGES FOR DIFFERENT TYPES OF SKIN AND WOUNDS. MY MOTHER HAS DEEP SCARRING FROM THE COMPRESSION BANDAGES THAT WERE APPLIED TO HER SKIN TEARS THAT WILL PROBABLY NEVER HEAL FULLY. I HAVE ATTACHED A COPY OF MY MOTHERS ARM AND A COPY OF THE BANDAGE USED. I HAVE ALREADY BROUGHT THIS TO THE ATTENTION OF THE HOSPITAL, ONLY TO HEAR ABSOLUTELY NO REPLY WHATSOEVER. I HOPE THAT YOU WILL ADDRESS THIS ISSUE SO THAT NO ONE ELSE MUST SUFFER AS MY MOTHER HAS FROM THIS UNFORTUNATE EVENT AND MISUSE OF YOUR "APPROVED" PRODUCT. DATED (B)(4) 2013, ACCORDING TO YOUR INFORMATION (ENCLOSED COPY) THE TESTING DONE ON THIS PRODUCT WAS ANTIMICROBIAL EFFECT TESTS ONLY. NO CLINICAL TESTING WAS REQUIRED AND IT WAS CONCLUDED THAT THIS WAS PREDICATE WITH RESPECT TO "INTENDED USE." HOWEVER, I FEEL THAT IF MEDICAL PROFESSIONALS MAY NOT BE AWARE OF THIS PRODUCT'S "INTENDED USE," THERE SHOULD BE A PACKAGE INSERT STATING THE IMPORTANCE OF SPECIFIC INTENDED USE, AND WARNINGS IF THE PRODUCT IS NOT USED IN ACCORDANCE TO PACKAGE INSTRUCTIONS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
570429 MEPILEX BORDER AG MEPILEX BORDER AG FRO MOLNLYCKE HEALTH CARE US, LLC

Patients

Seq Age Sex Outcome Treatment
1 86 YR Required Intervention