MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-12 for LISTERINE ULTRACLEAN ACCESS FLOSSER REPLACE HEADS MINT 12547386462 manufactured by Johnson & Johnson Consumer Inc.
[145942297]
Device was used for treatment, not diagnosis. The lot number was not reported. The udi number is (b)(4). Expiration date= na, lot number = ni. 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. Device history records review could not be completed without 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
[145942298]
A consumer reported through social medical an issue with the listerine ultraclean access flosser refill. The floss broke from the holder and that the plastic floss holder slips out of the handle with tight contacts. There was no consumer adverse event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8041101-2019-00037 |
| MDR Report Key | 8509126 |
| Report Source | CONSUMER |
| Date Received | 2019-04-12 |
| Date of Report | 2019-03-19 |
| Date Mfgr Received | 2019-03-19 |
| Date Added to Maude | 2019-04-12 |
| 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 ULTRACLEAN ACCESS FLOSSER REPLACE HEADS MINT |
| Generic Name | DENTAL FLOSS |
| Product Code | JES |
| Date Received | 2019-04-12 |
| Model Number | 12547386462 |
| 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 085589418 US 085589418 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-12 |