MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS REACH FLOSS WAXED 55YD; DENTAL FLOSS

Model Number 0041802738

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This foreign report is being submitted on (b)(6) 2016 for a device product that is considered same/similar to a us marketed device (reach j& (b)(4) floss waxed 55yd).This closes out this report unless additional significant information is received.

Event Description

This spontaneous report was received on (b)(6) 2015 from a consumer (age and gender unspecified) reporting on self from (b)(6).On an unspecified date, the consumer used reach floss waxed 55yd,once (route: dental, lot number 2524d, expiration date and indication unspecified).During the first use, the cutter came off the container while the consumer was pulling out the string.This report had no adverse event and the action taken with the device was unknown.This report was considered a reportable malfunction in the united states of america.

Manufacturer Narrative

This foreign report is being submitted on 24-feb-2016 for a device product that is considered same/similar to a us marketed device (rereach j&j floss waxed 55yd).This closes out this report unless additional significant information is received.

Event Description

This spontaneous report was received on (b)(6) 2015 from a consumer (age and gender unspecified) reporting on self from (b)(6).On an unspecified date, the consumer used reach floss waxed 55yd, once (route: dental, lot number 2524d, expiration date and indication unspecified).During the first use, the cutter came off the container while the consumer was pulling out the string.This report had no adverse event and the action taken with the device was unknown.This report was considered a reportable malfunction in the united states of america.Additional information was received on 09-feb-2016.A review of complaint data revealed no unfavorable trends for the reported lot number.Analysis of the product and complaint category will be managed through the monthly trending process.Device history records were reviewed and no deviations or non-conformances were found.A visual inspection was performed on the retained samples and all results met specification.Based on the investigation results, there is no evidence that a device malfunction occurred.Based on the available information, the device was used for intended treatment.The complaint investigation was closed with a disposition of undetermined.Complaint trends will continue to be monitored.This report had no adverse event.This report remains as a reportable malfunction in the united states of america.

• Brand Name: REACH FLOSS WAXED 55YD
• Type of Device: DENTAL FLOSS
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER PRODUCTS; parque industrial itabo haina; san cristobal ; DR
• Manufacturer (Section G): JOHNSON & JOHNSON CONSUMER PRODUCTS; parque industrial itabo haina; ni; san cristobal ; DR
• Manufacturer Contact: julie thomas ; johnson & johnson consumer inc; 199 grandview road; skillman, NJ 08558 ; 9082557895
• MDR Report Key: 5375827
• MDR Text Key: 36290693
• Report Number: 8041101-2016-00003
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 0041802738
• Device Lot Number: 2524D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Removal/Correction Number: NI
• Patient Sequence Number: 1