MAUDE Adverse Event Report: MÖLNLYCKE HEALTH CARE MEPILEX DRESSING; DRESSING, WOUND, HYDROPHILIC

Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Skin Inflammation/ Irritation (4545)
Date of Event	04/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
I am a healthy 49-year-old female, bmi 20, non-smoker, non-drinker.An unruptured ica aneurysm was discovered during a cta, and i had a stent placed to reduce the aneurysm via catheter through my wrist on (b)(6) 2024.To monitor my response to the procedure, i was placed in the neurology icu for 2 days where the protocol is to place a mepilex dressing on every patient's lower back to prevent bedsores.This dressing was placed within 1 hour of my being admitted to the icu for observation.When i left the hospital, i removed the dressing and thoroughly cleaned the area under the dressing.Over the following days, a poison-ivy like rash developed in the entire site that had previously been covered by the mepilex dressing (not the adhesive around the edges).The rash has been extremely itchy and covered with fluid-filled pustules.I have cleaned the area additional times, and i have used hydrocortisone cream (otc) daily.I am now on day 10 after the mepilex dressing was placed, and the rash is just now starting to reduce.It is still extremely itchy, but the bumps have reduced to approximately 25% of their original size.I did contact the hospital to ask for information about the dressing that was placed on my back.A nurse responded that she contacted the icu team leader to learn that the dressing used on my lower back was mepilex.I have searched published articles about allergic reactions to mepilex dressings, and i have found very little information.This is why i am reporting the event.I believe that allergic reactions to mepilex dressings should be investigated further as my reaction has made my recovery extremely difficult.

• Brand Name: MEPILEX DRESSING
• Common Device Name: DRESSING, WOUND, HYDROPHILIC
• Manufacturer (Section D): MÖLNLYCKE HEALTH CARE
• MDR Report Key: 19261468
• Report Number: MW5154627
• Device Sequence Number: 14780687
• Product Code: NAC
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2024
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White