MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2019-04-04 for REACH DENTOTAPE 100M EU 87159035 DTAWA45686EUA 381370092216 manufactured by Johnson & Johnson Consumer Inc.
[140950130]
Device was used for treatment, not diagnosis. Patient identifier, age at time of event, sex, weight and ethnicity and race were not provided for reporting. This report is for (reach dentotape 100m eu 87159035 dtawa45686eua). Device is not distributed in the united states, but is similar to device marketed in the usa (reach j&j floss dentotape 100yd usa (b)(4)). Udi #: (b)(4), upc = (b)(4), expiration date= na, lot number = 1038d. Device is not expected to be returned for manufacturer review/investigation. Device is not distributed in the united states, but is similar to device marketed in the usa (reach j& j floss dentotape 100yd usa (b)(4)). 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. (b)(4). 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
[140950131]
A consumer reported that reach dentotape was used and the thread divided and got stuck between the teeth. The consumer stated that the consumer had received a repairing/filling in the tooth and a half tooth disappeared after device use. There is no additional information at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8041101-2019-00036 |
| MDR Report Key | 8483902 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2019-04-04 |
| Date of Report | 2019-04-28 |
| Date Mfgr Received | 2019-04-28 |
| Device Manufacturer Date | 2018-04-13 |
| Date Added to Maude | 2019-04-04 |
| 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 | REACH DENTOTAPE 100M EU 87159035 DTAWA45686EUA |
| Generic Name | DENTAL FLOSS |
| Product Code | JES |
| Date Received | 2019-04-04 |
| Model Number | 381370092216 |
| Lot Number | 1038D |
| 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 085589418 US 085589418 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-04 |