MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-05-01 for LISTERINE GENTLE GUM CARE FLOSS MINT 12547440157 manufactured by Johnson & Johnson Consumer Products Inc.
[145942099]
Device was used for treatment, not diagnosis. (b)(4). Expiration date= na, lot number = 1598d. 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
[145942100]
A female consumer reported that the listerine gentle gum care floss mint metal cutter separated from the plastic insert. The consumer stated that when trying to use the floss, the spool came out of the container and the metal cutter broke off completely from the plastic insert. There were no adverse events associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8041101-2019-00040 |
| MDR Report Key | 8569594 |
| Report Source | CONSUMER |
| Date Received | 2019-05-01 |
| Date of Report | 2019-05-19 |
| Date Mfgr Received | 2019-05-19 |
| Device Manufacturer Date | 2018-06-08 |
| Date Added to Maude | 2019-05-01 |
| 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 | JOHNSON & JOHNSON CONSUMER PRODUCTS DR PARQUE INDU |
| Manufacturer Street | 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 | 2019-05-01 |
| Model Number | 12547440157 |
| Lot Number | 1598D |
| 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 PRODUCTS INC |
| Manufacturer Address | 199 GRANDVIEW RD SKILLMAN NJ 085589418 US 085589418 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-01 |