MAUDE MDR 7494382

MDR report key
7494382
Report number
MW5077077
Event key
0
Event type
3
Date of event
2018-05-02
Date received
2018-05-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LASER EYE SAFETY GLASSESSHIELD, EYE, RADIATIONUNKIWSI Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-05-0701. S

Event Narratives#

D

Patient 1

I ORDERED EYE PROTECTION FROM AMAZON FOR USE WITH LASER LIGHTS. WHEN I OPENED THE PACKAGE THE TOXIC CHEMICALS, FROM WHICH THE GLASSES AND CASE WERE MADE, CAUSED AN IMMEDIATE AND SEVERE REACTION. MY LOWER BODY CRAMPED SO SEVERELY I WAS UNABLE TO WALK. I HAD BREATHING PROBLEMS. RIGHT NOW I HAVE A SEVERE HEADACHE. I WAS EXPOSED FOR LESS THAN 3 MINS. IT TOOK ABOUT 20 MINS FOR THE CRAMPS TO SUBSIDE. I WILL PLACE THE PRODUCTS IN A PLASTIC BAG. THE PRODUCT WAS MANUFACTURED IN (B)(4) AND I THINK IT SHOULD BE ANALYZED FOR TOXICITY, BUT I DO NOT KNOW WHERE TO TAKE IT. I WOULD LIKE TO KNOW WHERE TO TAKE THIS PRODUCT TO BE ANALYZED. I HAVE FILED A COMPLAINT WITH BOTH AMAZON AND THE DISTRIBUTOR. THE NAME OF THE PRODUCT IS HDE EYE SAFETY LASER PROTECTION GLASSES. THE DISTRIBUTOR IS HDE. "IS THE PRODUCT OVER-THE-COUNTER: YES, STRENGTH: TOXIC MATERIALS, DID THE PROBLEM STOP AFTER THE PERSON REDUCED THE DOSE OR STOPPED TAKING OR USING THE PRODUCT: YES, DID THE PROBLEM RETURN IF THE PERSON STARTED TAKING OR USING THE PRODUCT AGAIN: YES, HOW WAS IT USED: PROTECTS EYES MATERIAL TOXIC." DATE THE PERSON FIRST STARTED TAKING OR USING THE PRODUCT: (B)(6) 2018, DATE THE PERSON STOPPED TAKING OR USING THE PRODUCT: (B)(6) 2018. REASON FOR USE: TO PROTECT EYES FROM ACNE LASER FOR SKIN.