MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS FLOSS / TAPE AP; 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 09-feb-2016 for a device product that is considered same/similar to a us marketed device (reach j&j floss waxed).This closes out this report unless additional significant information is received.

Event Description

This spontaneous report was received on 12-jan-2016 from a consumer (age and gender unspecified) reporting for self from (b)(6).The medical history and concomitant medications were not reported.On an unspecified date, the consumer started using reach floss waxed (route: dental, lot number, expiration date, frequency, and indication unspecified).After an unspecified duration, the consumer noticed the part of the container where the cutter was attached was broken.The consumer was regular user of the device, however, this was the first time this problem occurred with the device.This report had no adverse event and the action taken with the device was unknown.On 18-jan-2016, the field sample was received.Based on the quality investigation, the metal cutter was not intact and the metal cutter broke off completely from the plastic insert inside the container.The plastic insert was broken.The cutter breakage included plastic insert parts.The complaint was closed with the disposition of undetermined.This report was considered as reportable malfunction in the united states of america.

• Brand Name: FLOSS / TAPE AP
• 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: 5418408
• MDR Text Key: 37730548
• Report Number: 8041101-2016-00008
• 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
• Report Date: 01/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2016
• Event Location: Other
• Initial Date Manufacturer Received: 01/12/2016
• Initial Date FDA Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Removal/Correction Number: NI
• Patient Sequence Number: 1