MAUDE Adverse Event Report: SEAL TIGHT CAST AND BANDAGE PROTECTOR; COVER, CAST

Model Number ARM PROTECTOR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Urticaria (2278)

Event Type  Injury  

Event Description

Used an arm protector to bathe after elbow surgery (b)(6)2017.Bathed late (b)(6)2017 after using arm protector.Bathed again using arm protector and about an hour later, noticed large hives on my surgery arm at the bicep area.The hives and itching worsened and hives surrounded my upper bicep including the under arm area.Went to the er at (b)(6) here and it was determined to be a topical dermatitis.Was given script for prednisone pack and antihistamine.Early this am still had hives and was reviewing all that was new that might be implicated in this.Realized i had used an arm protector (otc) and looked at the device's info on the device.I am highly reactive to latex but there was nothing on the printed info nor on the info online to suggest latex.The product is made in (b)(4)."seal-tight cast and bandage protector." this is my third arm surgery and have used the product last about 2 years ago.This was a new purchase and had never had a problem prior.The hives have lessened but not totally abated."is this info used to you - they advertise products for kids through adults, which concerns me.And what else can i do?" thank you in advance for your attention in this matter.(b)(6).

• Brand Name: SEAL TIGHT CAST AND BANDAGE PROTECTOR
• Type of Device: COVER, CAST
• MDR Report Key: 6809659
• MDR Text Key: 83454450
• Report Number: MW5071722
• Device Sequence Number: 1
• Product Code: KIA
• 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

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: ARM PROTECTOR
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 82