MAUDE Adverse Event Report: DEALMED - NEW JERSEY DISTRIBUTION CENTER DEALMED KNUCKLE BAND AIDES; BANDAGE, ELASTIC

Device Problem Adhesive Too Strong (4071)

Patient Problem Hematoma (1884)

Event Date 05/30/2023

Event Type  Injury  

Event Description

I used several dealmed brand knuckle band aides on my arm and could not get them off until i used olive oil for 10-15 minutes and then i had hematomas under my skin where the adhesive was.My husband contacted dealmed and sent them a picture of my arm, but they have not gotten back to us.This could be an extreme problem for a diabetic, which i am not but i am concerned that someone else will have a greater problem.This product needs to be taken off the shelf.

• Brand Name: DEALMED KNUCKLE BAND AIDES
• Type of Device: BANDAGE, ELASTIC
• Manufacturer (Section D): DEALMED - NEW JERSEY DISTRIBUTION CENTER
• MDR Report Key: 17080472
• MDR Text Key: 316809327
• Report Number: MW5118241
• Device Sequence Number: 1
• Product Code: FQM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: PREMARIN AND SYNTHROID.
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White