SEAL TIGHT CAST AND BANDAGE PROTECTOR ARM PROTECTOR UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-22 for SEAL TIGHT CAST AND BANDAGE PROTECTOR ARM PROTECTOR UNK manufactured by Unk.

Event Text Entries

[83454450] 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).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5071722
• MDR Report Key: 6809659
• Date Received: 2017-08-22
• Date Added to Maude: 2017-08-22
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: SEAL TIGHT CAST AND BANDAGE PROTECTOR
• Generic Name: COVER, CAST
• Product Code: KIA
• Date Received: 2017-08-22
• Model Number: ARM PROTECTOR
• Catalog Number: UNK
• Lot Number: UNK
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UNK
• Manufacturer Address: UNK UNK

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2017-08-22