PERIO PROTECT TRAYS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-19 for PERIO PROTECT TRAYS manufactured by .

Event Text Entries

[5010191] I went to see dr. (b)(6) about two years ago and he told me that i have a gum disease. He told me that i need a deep cleaning and afterwards i would need "perio trays" for my periodontal disease. He had perio gel and vibramycin in his office that he sold me to use in the perio trays. He told me to wear the trays every night for 20 minutes per night using both medications. He gave me two cases to store the perio trays in, and he wrote "p. P. T. " on them for perio protect trays. I used the trays every night for nearly two years, returning to his office for additional medication when i would run out. Eventually, the trays and medication began to burn my gums. My gums would burn throughout the night and eventually stop burning the next day. I went to see him, and he told me that there must be something that i am doing wrong, and there was nothing wrong with the perio protect trays. After a couple of months of continual burning of my gums every night, i decided to stop wearing the perio protect trays. After a couple of months of continual burning of my gums every night, i decided to stop wearing the perio trays. On (b)(6) 2014, i went to see dr. (b)(6) and i showed him my perio trays. Dr. (b)(6) told me that the trays dr. (b)(6) gave me are not perio protect trays. Dr. (b)(6) showed me what perio trays look like, and they are not even close to what dr. (b)(6) gave me. Dr. (b)(6) called his trays "perio protect trays" by name when describing them and teaching me how to use them, but on the ledger he calls them "gum protection trays". Dr. (b)(6) took photographs of the trays that dr. (b)(6) fabricated, along with the storage cases that dr. (b)(6) wrote, '"p. P. T. " on.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5039217
MDR Report Key4277030
Date Received2014-11-19
Date of Report2014-11-19
Date of Event2012-09-28
Date Added to Maude2014-11-26
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NamePERIO PROTECT TRAYS
Generic NamePERIO PROTECT TRAYS
Product CodeKMT
Date Received2014-11-19
OperatorLAY USER/PATIENT
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2014-11-19

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