MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-11-08 for LISTERINE SENSITIVITY ZERO ALCOHOL MOUTHRINSE FRESH MINT 312547235976 manufactured by Johnson & Johnson Consumer Inc.
[126573820]
Device was used for treatment, not diagnosis. Ethnicity/race were not provided for reporting. Udi: (b)(4). Device is not expected to be returned for manufacturer review/investigation. Concomitant medical products and therapy dates: drug: unspecified thyroid medication; 1x daily; consumer still on drug. Drug: unspecified high blood pressure medication; 1x daily; consumer still on drug. (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. This is one of two medwatches being submitted as two devices were involved with this consumer. See medwatch 2214133-2018-00052. The same consumer is represented in each medwatch. 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
[126573821]
A 5'8", (b)(6) male consumer reported an adverse event while using listerine sensitivity mouthwash. The consumer orally used, a couple teaspoons-full, twice a day of listerine sensitivity mouthwash and he developed sloshing of his gums, sores and the listerine burns his gums. The consumer states that he had tremendous discomfort while using the product. This was the consumer's first time using the product and it was to help with tooth sensitivity. Consumer was not certain the start date or length of use. Consumer has never had a similar experience before and is still experiencing peeling of his gums. Consumer did go to the orthodontist and his hcp recommended to discontinue use of the product, rinse with salt water, take ibuprofen, and a prescription mouthwash. Consumer did not go to the er and did not receive laboratory testing. Consumer is still experiencing the symptoms. This is one of two medwatches being submitted as two devices were involved with this consumer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2214133-2018-00051 |
| MDR Report Key | 8052149 |
| Report Source | CONSUMER |
| Date Received | 2018-11-08 |
| Date of Report | 2018-11-15 |
| Date Mfgr Received | 2018-11-15 |
| Device Manufacturer Date | 2017-10-18 |
| Date Added to Maude | 2018-11-08 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | 2018-11-08 |
| Model Number | 312547235976 |
| Lot Number | 29317CA |
| Device Expiration Date | 2019-09-30 |
| 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 | 2018-11-08 |