MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-26 for LISTERINE GENTLE GUM CARE FLOSS MINT 12547440157 manufactured by Johnson & Johnson Consumer Inc.
[145942226]
Device was used for treatment, not diagnosis. (b)(4). Lot number: (10)1158d, expiration date: na. Product was returned for investigation for a broken cutter. Upon visual evaluation of the returned device, it was noted that the metal cutter was completely separated from the insert assembly. It is unknown how the product was being used at the time. Additional evaluation is pending from manufacturing site. Device history records review was completed. No non-conformance reports were generated during production. Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition and product was manufactured per specification. The product was manufactured on april 25, 2018. 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
[145942227]
A male consumer reported that while using listerine gentle gum care floss mint 50yd the metal cutter was falling off the plastic insert.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8041101-2019-00038 |
| MDR Report Key | 8554607 |
| Report Source | CONSUMER |
| Date Received | 2019-04-26 |
| Date of Report | 2019-05-08 |
| Date Mfgr Received | 2019-05-08 |
| Device Manufacturer Date | 2018-04-25 |
| Date Added to Maude | 2019-04-26 |
| 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 | 2019-04-26 |
| Returned To Mfg | 2019-04-09 |
| Model Number | 12547440157 |
| Lot Number | 1158D |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-04-26 |