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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRESTIGE BRANDS INC. DENTEK MAXIUMUM PROTECTION DENTAL GUARD; MOUTHGUARD, OVER-THE-COUNTER
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PRESTIGE BRANDS INC. DENTEK MAXIUMUM PROTECTION DENTAL GUARD; MOUTHGUARD, OVER-THE-COUNTER Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Abdominal Pain (1685); Foreign Body In Patient (2687)
Event Date 12/08/2018
Event Type  Injury  
Event Description
On (b)(6) 2018, a male consumer used a dentek maximum protection dental guard for an unknown indication and experienced stomach pains after accidentally swallowing the device.The consumer did not provide his age, medical history, concomitant medications or allergies.The duration and frequency of use of the mouthguard were not reported.The consumer stated he had issues fitting the device and it was loose in his mouth.He went to the emergency room for the abdominal pains and was advised that he "should pass the device or it would cause a blockage".The case outcome was not resolved at the time of contact with consumer, and he was advised to contact company with any updates or changes in his condition.
 
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Brand Name
DENTEK MAXIUMUM PROTECTION DENTAL GUARD
Type of Device
MOUTHGUARD, OVER-THE-COUNTER
Manufacturer (Section D)
PRESTIGE BRANDS INC.
4615 murray place
lynchburg VA 24502
Manufacturer Contact
prestige brands pv & safety
4615 murray place
lynchburg, VA 24502
MDR Report Key8233808
MDR Text Key132624757
Report Number3003283852-2019-00001
Device Sequence Number1
Product Code OBR
Combination Product (y/n)N
PMA/PMN Number
K091660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 01/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Date Manufacturer Received01/05/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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