MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-06-27 for LISTERINE?SENSITIVITY ZERO ALCOHOL MOUTHRINSE FRESH MINT 312547235976 manufactured by Johnson & Johnson Consumer Inc.
[112549781]
Device was used for treatment, not diagnosis. Age/date of birth, weight 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 history records review was completed. No non conformance reports were generated during production. Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition and product was manufactured per specification. Product was manufactured on october 28, 2017. 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
[112549782]
A female consumer called to report an event with listerine sensitivity mouthwash for her tooth sensitivity. Consumer reported that after using the mouthwash, used 10 ml twice daily for 5-6 days, she had a blocked salivary gland. The consumer experienced pain and shedding of cheek lining and/or gum tissue in the mouth. Consumer sought attention from a health care professional who prescribed oral antibiotics to treat the blocked salivary glands. The consumer was also advised to drink plenty of fluids, massage the gland area and eat sour candy to help reactivate the salivary gland. The salivary glands are recovering and the shedding has resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2214133-2018-00020 |
| MDR Report Key | 7643157 |
| Report Source | CONSUMER |
| Date Received | 2018-06-27 |
| Date of Report | 2018-06-06 |
| Date Mfgr Received | 2018-06-06 |
| Device Manufacturer Date | 2017-10-28 |
| Date Added to Maude | 2018-06-27 |
| 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 | 2018-06-27 |
| Model Number | 312547235976 |
| Lot Number | 30517CB |
| ID Number | (01)312547235976 |
| Device Expiration Date | 2019-09-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 2018-06-27 |