SOLUMBRA CLOTHING MEDICAL DEVICE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-06-18 for SOLUMBRA CLOTHING MEDICAL DEVICE * manufactured by Sun Precautions.

Event Text Entries

[273531] Anaphylaxis. Regarding specialized clothing made by the company: sun precautions. Their clothing line is called solumbra. They claim the clothing is a medical device" designed to protect the wearer from the sun. Reporter was told the clothing was safe, and that nothing about it should be a health concern. Reporter was encouraged to order it and try it. Reporter asked if it would be ok if they washed it prior to trying it on. They agreed that was ok. They washed the items as they normally wash clothing with the same detergent etc. Upon trying the clothing on, in the house, a shirt, pant and hat, within minutes of putting the final garment on reporter broke out into a rash, hives, itchy all over where the clothing touched. Their skin began to swell up, their tongue also. Reporter got dizzy and started to have a hard time breathing. Emergency antihistamines were administered.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1028776
• MDR Report Key: 467745
• Date Received: 2003-06-18
• Date of Report: 2003-06-18
• Date of Event: 2003-05-31
• Date Added to Maude: 2003-06-26
• 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: 0
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: SOLUMBRA CLOTHING MEDICAL DEVICE
• Generic Name: SUN PROTECTIVE CLOTHING
• Product Code: MIW
• Date Received: 2003-06-18
• Returned To Mfg: 2003-06-07
• Model Number: SOLUMBRA CLOTHING MEDICAL DEVICE
• Catalog Number: *
• Lot Number: *
• ID Number: STYLE #1530K0
• Operator: LAY USER/PATIENT
• Device Availability: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 456670
• Manufacturer: SUN PRECAUTIONS
• Manufacturer Address: 2815 WETMORE AVENUE EVERETT WA 98201 US

Device Sequence Number: 2

• Brand Name: SOLUMBRA CLOTHING MEDICAL DEVICE
• Generic Name: SUN PROTECTIVE CLOTHING
• Product Code: MIW
• Date Received: 2003-06-18
• Returned To Mfg: 2003-06-07
• Model Number: SOLUMBRA CLOTHING MEDICAL DEVICE
• Catalog Number: *
• Lot Number: *
• ID Number: STYLE# 2140K03
• Operator: LAY USER/PATIENT
• Device Availability: R
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 456673
• Manufacturer: SUN PRECAUTIONS
• Manufacturer Address: 2815 WETMORE AVENUE EVERETT WA 98201 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening; 2. Required No Informationntervention	2003-06-18