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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANIR LLC WALGREENS ORTHO WX 2PK; WAX, DENTAL, INTRAORAL
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RANIR LLC WALGREENS ORTHO WX 2PK; WAX, DENTAL, INTRAORAL Back to Search Results
Model Number ORTHO WX 2PK CD
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Swelling (2091)
Event Date 08/15/2019
Event Type  malfunction  
Event Description
Consumer used the orthodontic wax and claims she had an allergic reaction, she had itching/swelling.Consumer followed up saying that she can't pinpoint whether or not this reaction was related to the product as she's been having a lot of "different allergic things going on." she said "the problem stopped.I switched to another brand.It may or not have been the product.I was more curious about the ingredients.".
 
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Brand Name
WALGREENS ORTHO WX 2PK
Type of Device
WAX, DENTAL, INTRAORAL
Manufacturer (Section D)
RANIR LLC
4701 east paris ave. se
grand rapids MI 49512 5353
Manufacturer (Section G)
RANIR LLC
4701 east paris ave. se
grand rapids MI 49512 5353
Manufacturer Contact
rebekah stenske
4701 east paris ave. se
grand rapids, MI 49512-5353
6166988880
MDR Report Key8976125
MDR Text Key167636499
Report Number1825660-2019-00612
Device Sequence Number1
Product Code EGD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 09/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberORTHO WX 2PK CD
Was Device Available for Evaluation? No
Distributor Facility Aware Date08/16/2019
Initial Date Manufacturer Received 08/16/2019
Initial Date FDA Received09/09/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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