CHILD SIZE SAFETY GOGGLES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-26 for CHILD SIZE SAFETY GOGGLES manufactured by Unk.

Event Text Entries

[74145770] I work for an occupational safety work center so it is our responsibility to ensure all work centers on our installation are following the federal regulations set by osha and the u. S. Air force. While on an inspection of a work center, one of our inspectors came across some child safety goggles in one of our youth work centers. They were still in the package so the inspector picked them up to ensure they meet ansi z87. 1 standards. As they were picked up the lenses cracked. The safety goggles did have a "z87" stamp on the goggles but there was no manufacturer's stamp on them. Only a "(b)(6)" stamp was found on the goggles. The goggles were manufactured by (b)(4), part number 190-0030, child size safety goggles. Do these goggles meet ansi z87. 1 standards or is there a chance they would be fake? Incident location: (b)(4). Product description: delta education child size safety goggles, part number 190-0030. Blue strap. Cranked in the packaging upon picking up. No manufacturer's stamp located on the goggles, only a "z87" and "(b)(6)" stamp was found. Brand name: (b)(4). Manufacturer/ importer: (b)(4). Document number: (b)(4). Report number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5069379
MDR Report Key6529379
Date Received2017-04-26
Date of Report2017-04-17
Date Added to Maude2017-04-28
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCHILD SIZE SAFETY GOGGLES
Generic NameSAFETY GOGGLES
Product CodeHOY
Date Received2017-04-26
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK


Patients

Patient NumberTreatmentOutcomeDate
10 2017-04-26

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