MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-10-29 for LISTERINE GENTLE GUM CARE FLOSS MINT 12547440157 manufactured by Johnson & Johnson Consumer Inc.
[179400400]
Device was used for treatment, not diagnosis. Patient ethnicity and race was not provided for reporting. Udi: (b)(4), upc = (01)12547440157, expiration date= ni, lot number = 34118d. Device is not expected to be returned for manufacturer review/investigation. 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
[179400401]
A male consumer reported and event with listerine gentle gum care floss mint on (b)(6) 2019. The consumer stated that he had to seek medical attention from his dentist to remove the crown in his implant in order to remove the floss. The dentist put back the implant after removal. The consumer is still experiencing pain in the jaw.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8041101-2019-00054 |
| MDR Report Key | 9250897 |
| Report Source | CONSUMER |
| Date Received | 2019-10-29 |
| Date of Report | 2019-11-11 |
| Date of Event | 2019-09-01 |
| Date Mfgr Received | 2019-11-11 |
| Device Manufacturer Date | 2018-12-07 |
| Date Added to Maude | 2019-10-29 |
| 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 | LAURIE RAUCO |
| Manufacturer Street | 199 GRANDVIEW RD |
| Manufacturer City | SKILLMAN NJ 085589418 |
| Manufacturer Country | US |
| Manufacturer Postal | 085589418 |
| Manufacturer Phone | 2152734905 |
| Manufacturer G1 | JOHNSON & JOHNSON CONSUMER PRODUCTS DR PARQUE INDU |
| Manufacturer Street | PARQUE INDUSTRIAL DE ITABO CARRETERA S |
| Manufacturer City | HAINA 91000 |
| Manufacturer Country | DR |
| Manufacturer Postal Code | 91000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LISTERINE GENTLE GUM CARE FLOSS MINT |
| Generic Name | DENTAL FLOSS |
| Product Code | JES |
| Date Received | 2019-10-29 |
| Model Number | 12547440157 |
| Lot Number | 34118D |
| 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 08558 US 08558 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-10-29 |