MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-08-01 for LISTERINE SENSITIVITY ZERO ALCOHOL MOUTHRINSE FRESH MINT 312547235976 manufactured by Johnson & Johnson Consumer Inc.
[115724268]
Device was used for treatment, not diagnosis. Date of birth and ethnicity/race were not provided for reporting. Udi: (b)(4). Device is not expected to be returned for manufacturer review/investigation. (b)(4). Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. A review of the device history records has been requested. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[115724269]
A (b)(6) male consumer, weighing (b)(6) called to report that his most recent use of listerine left blisters in his mouth. Patient states he has been using listerine sensitivity zero alcohol mouthrinse fresh mint for general oral hygiene. Patient states that his first use of a newly purchased bottle produced blisters in his mouth on his upper gums. Patient states he only used this new bottle once on (b)(6) 2018 and immediately got blisters. Patient indicates he has stopped use of that bottle and his dentist is not aware of product use. Patient reports that he treated the blisters with rinsing his mouth with peroxide and using a rx oral base from his dentist. Patient states that with treatment the blisters have gone down in size, but are still present. Consumer is recovering.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2214133-2018-00031 |
| MDR Report Key | 7740285 |
| Report Source | CONSUMER |
| Date Received | 2018-08-01 |
| Date of Report | 2018-08-02 |
| Date of Event | 2018-07-05 |
| Date Mfgr Received | 2018-08-02 |
| Device Manufacturer Date | 2017-10-21 |
| Date Added to Maude | 2018-08-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LINDA PLEWS |
| Manufacturer Street | 199 GRANDVIEW RD |
| Manufacturer City | SKILLMAN NJ 085589418 |
| Manufacturer Country | US |
| Manufacturer Postal | 085589418 |
| Manufacturer Phone | 2152737120 |
| Manufacturer G1 | KIK CUSTOM PRODUCTS - KIK REXDALE |
| Manufacturer Street | 2000 KIPLING AVENUE ETOBICOKE |
| Manufacturer City | ONTARIO M9W 4J6 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | M9W 4J6 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LISTERINE SENSITIVITY ZERO ALCOHOL MOUTHRINSE FRESH MINT |
| Generic Name | CAVITY VARNISH |
| Product Code | LBH |
| Date Received | 2018-08-01 |
| Model Number | 312547235976 |
| Lot Number | 29717CB |
| Device Expiration Date | 2019-09-20 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON CONSUMER INC |
| Manufacturer Address | 199 GRANDVIEW RD SKILLMAN NJ 085589418 US 085589418 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-01 |