MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-03 for GC TOOTH MOUSSE ( MARKETED IN THE U.S. UNDER BRAND NAME "MI PASTE") 462032 manufactured by Gc America Inc..
[140876781]
The autopsy report provided by the coroner indicates that the fatality is not likely related to anatomical, histological, toxicological or microbiological causes,while serology suggested levels of serum tryptase indicative of acute anaphylaxis /type1 hypersensitivity, reflecting mast cell activation. As noted, the pathologist noted in the autopsy report that if there was no other drug /toxin under consideration as an allergen, the tooth mousse /hydroxybenzoate was a potential /likely cause of the anaphylaxis. The instructions for use (ifu) for gc tooth mousse state that the product is for use by or under the supervision of a dental professional in the recommended indications. The contraindications listed in the ifu state: "do not use this material on patients with a proven or suspected milk protein allergy and/or with a sensitivity or allergy to benzoate preservatives". Gc tooth mousse provides extra protection for teeth, helps neutralize acid challenges from acidogenic bacteria in plaque and helps neutralize acid challenges from other internal and external sources. The ifu also states under the caution heading: "if any angioedema symptoms are experienced, this may indicate sensitivity or allergy to the benzoate preservatives, or to some other component of the product such as a flavoring agent. In this event, discontinue the use of the product and refer to a physician". The presence of benzoates is also identified on the packaging of gc tooth mousse, together with a similar warning. The coroner has not provided details of how the deceased acquired gc tooth mousse or whether or not it was used under the supervision of a dental professional for the recommended indications. Further, gc tooth mousse does not contain eggs or egg derivatives. The investigations are at a very early stage. The immediate actions to be undertaken are as follows: the instructions for use ( ifu) and packaging for gc tooth mousse will be critically re-evaluated within the context of both european and u. S. Regulatory requirements. Product risk management will be re-evaluated accordingly as well. Interim report/final report is expected to be available within two months. However, this estimate may be subject to change depending on the outcome of the coroner's enquiries and/or any inquest. Gc tooth mousse complies with all (b)(6) laws and regulations concerning the marketing and labeling of such products in (b)(6). In the u. S. , the device is marketed as an rx device with the brand name "mi paste," and was granted premarket clearance by fda pursuant to 510(k) k04220. Other than the different brand names between the (b)(6). And the u. S. Product (i. E. , "tooth mousse" in the (b)(6). ;"mi paste" in the u. S. ), the labeling, warnings, instructions and packaging are otherwise identical.
Patient Sequence No: 0, Text Type: N, H10
[140876782]
On (b)(6) 2019, gc corporation in (b)(4) (the parent company of gc america ) received a letter from the office of (b)(6) coroner ((b)(6) coroner) in connection with the coroner's enquiries into the death of a (b)(6) year old woman in (b)(6) on (b)(6) 2018. The autopsy report states that the deceased was discovered collapsed in a bath of water on (b)(6) 2018 and was brought, following paramedic intervention, to the emergency department at hospital where revival was not possible. The deceased was declared dead the same day. The cause of death in the autopsy report is given as acute anaphylaxis/ hydroxybenzoate hypersensitivity. The pathologist states in the autopsy report that following information provided by the family of the deceased, it was understood that the deceased likely applied gc tooth mousse prior to getting into the bath and noted that the compound lists hydroxybenzoate within its formulation ,with a warning that it should not be given to persons with egg protein or hydroxybenzoate sensitivity. The autopsy report continues that if there is no other drug/toxin under consideration as an allergen ,the tooth mousse/ hydroxybenzoate was a potential/likely cause of the anaphylaxis. The coroner's letter notes that the deceased was not known to have an allergy to egg protein or hydroxybenzoate.
Patient Sequence No: 0, Text Type: D, B5
| Report Number | 1410097-2019-00002 |
| MDR Report Key | 8480913 |
| Date Received | 2019-04-03 |
| Date of Report | 2019-04-03 |
| Date of Event | 2018-10-28 |
| Report Date | 2019-03-13 |
| Date Reported to Mfgr | 2019-03-13 |
| Date Mfgr Received | 2019-03-13 |
| Date Added to Maude | 2019-04-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. MARK HEISS |
| Manufacturer Street | 3737 W 127 STREET |
| Manufacturer City | ALSIP IL 60803 |
| Manufacturer Country | US |
| Manufacturer Postal | 60803 |
| Manufacturer Phone | 7089263090 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GC TOOTH MOUSSE ( MARKETED IN THE U.S. UNDER BRAND NAME "MI PASTE") |
| Generic Name | GC TOOTH MOUSSE (UNDER/OR "MI PASTE") |
| Product Code | EJR |
| Date Received | 2019-04-03 |
| Catalog Number | 462032 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GC AMERICA INC. |
| Manufacturer Address | 3737 W 127 STREET ALSIP IL 60803 US 60803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 0 | 0 | 1. Death | 2019-04-03 |