OPEN FACE LONG BALACLAVA - HOOD H-NWI-E-CROWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-16 for OPEN FACE LONG BALACLAVA - HOOD H-NWI-E-CROWN manufactured by Keystone Safety.

Event Text Entries

[70452078] Medical device manufacturer utilizing a disposable hood as part of gowning requirements for the clean room. A new disposable hood was introduced and almost immediately after introduction employees began experiencing contact dermatitis to the face, neck and foreheads. In less than a 10 day period there have been 5 reported cases to our occupational health department. The manufacturer was contacted about the reactions after the first 2 reports were made. The following response was received from the manufacturer: "the reaction is not to the elastic because it is synthetic elastic. Nor is it to the polypropylene. From my years of experience the people who are "allergic" to the hood are most likely experiencing an irritation to wearing the hood. Meaning they have more sensitive skin and the contact with the hood is irritating their skin. I've seen this before. What plants will do is have those people wear something else and continue the hood because it is very effective. I have a hood made of a softer material i can sample you on. It is more of a netting but more expensive. I will send you some samples. Perhaps you have the people who have a skin irritation to the poly hood wear the hood from netting. Been down this road before. Communication with the manufacturer to date has been left unanswered and orders are no longer being filled.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5068528
• MDR Report Key: 6416702
• Date Received: 2017-03-16
• Date of Report: 2017-03-16
• Date of Event: 2017-03-06
• Date Added to Maude: 2017-03-20
• 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: UNKNOWN
• 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: OPEN FACE LONG BALACLAVA - HOOD
• Generic Name: PROTECTIVE HOOD
• Product Code: FXY
• Date Received: 2017-03-16
• Model Number: H-NWI-E-CROWN
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: KEYSTONE SAFETY
• Manufacturer Address: 1591 HYLTON ROAD PENNSAUKEN NJ 08110 US 08110

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2017-03-16