MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-08-06 for LISTERINE?SENSITIVITY ZERO ALCOHOL MOUTHRINSE FRESH MINT manufactured by Johnson & Johnson Consumer Inc.
[116095908]
Device was used for treatment, not diagnosis. Patient identifier, age/date of birth, sex, weight and ethnicity/race were not provided for reporting. The upc, lot number and udi number are not available. 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. Device history records review could not be completed without a lot number. 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
[116095909]
Consumer alleges that they used the listerine sensitivity zero alcohol mouthrinse for a couple of days and a crown fell out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2214133-2018-00034 |
| MDR Report Key | 7752570 |
| Report Source | CONSUMER |
| Date Received | 2018-08-06 |
| Date of Report | 2018-07-24 |
| Date Mfgr Received | 2018-07-24 |
| Date Added to Maude | 2018-08-06 |
| 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 | 2018-08-06 |
| 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 ROAD SKILLMAN NJ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention; 2. Deathisabilit | 2018-08-06 |