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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALGREENS LOST FILLING AND LOOSE CAP REPAIR; CEMENT, DENTAL
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WALGREENS LOST FILLING AND LOOSE CAP REPAIR; CEMENT, DENTAL Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Swelling (2091); Burning Sensation (2146)
Event Date 11/19/2018
Event Type  Injury  
Event Description
This serious case reports a (b)(6) year old male using walgreens lost filling & loose cap repair on deteriorating teeth.He has a medical history of throat and mouth cancer.He reported tooth decay related to radiation and chemotherapy treatments.On (b)(6) 2018, the consumer used walgreens lost filling & loose cap repair for management of ongoing tooth decay and experienced mouth burning, blisters in mouth, throat swelling, pain and sores in mouth.He reported using this product in the past from walgreens as well as other brands and did not experience any type of reaction.The consumer reported removing the product from the mouth.Due to the reaction to this product, he was unable to eat for a week.He was taken to a local emergency department to get stabilized.Treatments required to stabilized consumer were not reported.
 
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Brand Name
WALGREENS LOST FILLING AND LOOSE CAP REPAIR
Type of Device
CEMENT, DENTAL
Manufacturer Contact
prestige brands pv & safety
4615 murray place
lynchburg, VA 24502
MDR Report Key8286457
MDR Text Key134399743
Report Number3006644229-2019-00002
Device Sequence Number1
Product Code EMA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 01/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Date Manufacturer Received01/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Age49 YR
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