MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-05-28 for LISTERINE SENSITIVITY ZERO ALCOHOL MOUTHRINSE FRESH MINT 312547235976 manufactured by Johnson And Johnson Consumer Inc.
[146275518]
Device was used for treatment, not diagnosis. Udi# (b)(4). Device is not expected to be returned for manufacturer review/investigation. Concomitant medical products and therapy dates: drug: 100 mg of unknown vitamins & unknown dates. 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 events were involved with this consumer. See medwatch 2214133-2019-00078 for second occurrence. 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
[146275519]
A male consumer reported an event (unknown date) with listerine sensitivity zero alcohol mouthrinse fresh mint. The consumer alleged that his face was swollen after use. The consumer stated he sought medical attention from his health care professional (hcp). The hcp gave the consumer an unknown shot and unknown antibiotic to treat his swollen face. Consumer stated the swelling subsided and went away post treatment. This is one of two medwatches being submitted as two events were involved with this consumer. See medwatch 2214133-2019-00078 for second occurrence. The same consumer is represented in each medwatch.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2214133-2019-00077 |
| MDR Report Key | 8647236 |
| Report Source | CONSUMER |
| Date Received | 2019-05-28 |
| Date of Report | 2019-05-28 |
| Date Mfgr Received | 2019-05-28 |
| Device Manufacturer Date | 2018-03-15 |
| Date Added to Maude | 2019-05-28 |
| 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 |
| Manufacturer City | ETOBICOKE, 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 | 2019-05-28 |
| Model Number | 312547235976 |
| Lot Number | 08018CA |
| 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 AND JOHNSON CONSUMER INC |
| Manufacturer Address | 199 GRANDVIEW ROAD SKILLMAN NJ 085589418 US 085589418 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 100 | 1. Required No Informationntervention | 2019-05-28 |