Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALIGN TECHNOLOGIES VIVERA RETAINERS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ALIGN TECHNOLOGIES VIVERA RETAINERS Back to Search Results
Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)
Patient Problems No Information (3190); No Code Available (3191); No Code Available (3191)
Event Date 01/02/2017
Event Type  malfunction  
Event Description
I am reporting a safety concern regarding materials used in my daughter's orthodontic treatment and presence of a characteristic smell in her breath following use of these products (i.E.Invisalign aligner material and orthodontic plastic retainers (vivera)).My daughter completed her invisalign orthodontic treatment and has now been prescribed vivera orthodontic retainers (plastic) for use each night to prevent her teeth from shifting.We have noticed a characteristic smell/breath from her mouth every time she uses these retainers.It is not the same as a "normal morning bad breath but similar to a ketonic breath".My wife noticed a similar kind of smell/breath from her mouth when she was on a strict high protein diet (which is believed to produce high levels of ketones).When my daughter stops using the retainers for a couple/few days, we notice the "smell" is gone.We had noticed this smell even earlier when she was on the initial invisalign orthodontic treatment (prior to starting the retainers) but was assured about the safety of the product by her orthodontist who also shared the product msds with us.We notice this smell again with the retainers.She is careful about following the routine care for her retainers, as instructed by her orthodontist i.E.Washing it with mouthwash etc.The msds for the invisalign aligners and retainers were provided by our orthodontist upon our request.My wife, a toxicologist, noticed that the msds for invisalign lists diisocyanates and the safety information from the makers of vivera retainers states that the product contains polyurethane resins (msds has more detailed information).As a toxicologist, she is concerned about the safety of these products because some diisocyanates are sensitizers and diisocyanate contain acidic groups that may break down to form aldehydes and ketones (and hence maybe the "ketonic breath" she noticed from our daughter's mouth due to breakdown of product), possibility of plasticizers/other chemicals (and associated reproductive/developmental toxicity/other) health effects that our daughter may be exposed to due to breakdown of the plastic orthodontic/retainer material in her mouth following grinding her teeth at night or reaction between the product material and saliva/salivary enzymes.As concerned parents and scientists, we request you to please investigate these materials and help provide assurance that these materials are safe for use by our daughter under the conditions of use.
 
Event Description
Add¿l info received on 02/06/2017 from reporter for report # mw5067452.I am reporting a safety concern regarding materials used in my daughter's orthodontic treatment and presence of a characteristic smell in her breath following use of these products (i.E.Invisalign aligner material and orthodontic plastic retainers (vivera)).My daughter completed her invisalign orthodontic treatment and has now been prescribed vivera orthodontic retainers (plastic) for use each night to prevent her teeth from shifting.I have noticed a characteristic smell/breath from her mouth every time she uses these retainers.It is not the same as a "normal morning bad breath" but similar to a "ketonic breath".I noticed a similar kind of smell/breath from my mouth when i was on a strict high protein diet (which is believed to produce high level of ketones).When my daughter stops using the retainers for a couple/few days, i notice the "smell" is gone.I had noticed this smell even earlier when she was on the initial invisalign orthodontic treatment (prior to starting the retainers) but was assured about the safety of the product by her orthodontist who also shared the product msds with me.I notice this smell again with the retainers.She is careful about following the routine care for her retainers, as instructed by her orthodontist i.E.Washing it with mouthwash etc.I am, attaching the msds for invisalign aligner material and the retainer for these two products from the manufacturers (both obtained from my orthodontist).I notice that the msds for invisalign lists diisocyanates and the safety information from the makers of vivera retainers states that the product contains polyurethane resins (msds has more detailed information).As a toxicologist i am concerned about the safety of these products because some diisocyanates are sensitizers and diisocyanate contains acidic groups that may break down to form aldehydes and ketones (and hence maybe the "ketonic breath" i notice from her mouth due to breakdown of product in her mouth) possibility of plasticizers/other chemicals (and associated reproductive/developmental toxicity/other) health effects that my daughter may be exposed to due to breakdown of the plastic orthodontic/retainer material in her mouth following grinding her teeth at night or reaction between the product material and saliva/salivary enzymes.As a concerned parent and scientist, i request you to please investigate these materials and help provide assurance that these materials are safe for use by my daughter under the conditions of use.P.S.I am an ex-employee of (b)(6) and am grateful for this database.Thank you!.
 
Event Description
I am reporting a safety concern regarding materials used in my daughter's orthodontic treatment and presence of a characteristic smell in her breath following use of these products (i.E.Invisalign aligner material and orthodontic plastic retainers (vivera)).My daughter completed her invisalign orthodontic treatment and has now been prescribed vivera orthodontic retainers (plastic) for use each night to prevent her teeth from shifting.We have noticed a characteristic smell/breath from her mouth every time she uses these retainers.It is not the same as a "normal morning bad breath but similar to a ketonic breath".My wife noticed a similar kind of smell/breath from her mouth when she was on a strict high protein diet (which is believed to produce high levels of ketones).When my daughter stops using the retainers for a couple/few days, we notice the "smell" is gone.We had noticed this smell even earlier when she was on the initial invisalign orthodontic treatment (prior to starting the retainers) but was assured about the safety of the product by her orthodontist who also shared the product msds with us.We notice this smell again with the retainers.She is careful about following the routine care for her retainers, as instructed by her orthodontist i.E.Washing it with mouthwash etc.The msds for the invisalign aligners and retainers were provided by our orthodontist upon our request.My wife, a toxicologist, noticed that the msds for invisalign lists diisocyanates and the safety information from the makers of vivera retainers states that the product contains polyurethane resins (msds has more detailed information).As a toxicologist, she is concerned about the safety of these products because some diisocyanates are sensitizers and diisocyanate contain acidic groups that may break down to form aldehydes and ketones (and hence maybe the "ketonic breath" she noticed from our daughter's mouth due to breakdown of product), possibility of plasticizers/other chemicals (and associated reproductive/developmental toxicity/other) health effects that our daughter may be exposed to due to breakdown of the plastic orthodontic/retainer material in her mouth following grinding her teeth at night or reaction between the product material and saliva/salivary enzymes.As concerned parents and scientists, we request you to please investigate these materials and help provide assurance that these materials are safe for use by our daughter under the conditions of use.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VIVERA RETAINERS
Type of Device
VIVERA RETAINERS
Manufacturer (Section D)
ALIGN TECHNOLOGIES
MDR Report Key6278949
MDR Text Key66002704
Report NumberMW5067452
Device Sequence Number2
Product Code DYT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial,Followup
Report Date 01/24/2017
3 Devices were Involved in the Event: 1   2   3  
2 Patient was Involved in the Event
Date FDA Received01/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Type of Device Usage N
Patient Sequence Number0
Treatment
OTC MEDS: CHILDREN'S MULTI-VITAMINS; RETAINERS AND CONTACT LENSES.; RX MEDS: NONE, OTHER THAN THE ORTHODONTIC
Patient Outcome(s) Other;
Patient Age16 YR
Patient Weight44
-
-