MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS JOHNSON & JOHNSON FLOSS, WAXED; DENTAL FLOSS

Model Number 8137009213

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The date of this submission is (b)(4) 2015.This closes out this report unless other 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 the united states of america.On an unspecified date, the consumer started using johnson and johnson floss, waxed (route-dental, lot number 3174d, frequency, expiration date unspecified) for general oral hygiene.After an unspecified duration when the consumer was using the last portion of the floss, the consumer noticed the plastic insert popped out and the metal cutter popped off while the consumer was pulling and cutting the floss.The consumer put it back together and tried to use the device again, but the same thing occurred.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

The date of this submission is 28-oct-2015.This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on 25-aug-2015 from a consumer (age and gender unspecified) reporting on self from the united states of america.On an unspecified date, the consumer started using johnson and johnson floss, waxed (route-dental, lot number 3174d, frequency, expiration date unspecified) for general oral hygiene.After an unspecified duration when the consumer was using the last portion of the floss, the consumer noticed the plastic insert popped out and the metal cutter popped off while the consumer was pulling and cutting the floss.The consumer put it back together and tried to use the device again, but the same thing occurred.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 01-oct-2015.The device was used for oral hygiene.A review of the data revealed no lot trend for the lot number 3174d.Final packaging records and packing records were reviewed and the review indicated the product did not present defects during production inspections and appropriate components were used.A retained sample was evaluated and met specifications for appearance.The complaint investigation was closed with a disposition of undetermined.Complaints trends will continue to be monitored.This report remains a reportable malfunction case in the united states of america.

• Brand Name: JOHNSON & JOHNSON FLOSS, WAXED
• Type of Device: DENTAL FLOSS
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER PRODUCTS; parque industrial itabo haina; san cristobal NI ; DR NI
• Manufacturer (Section G): JOHNSON & JOHNSON CONSUMER PRODUCTS; parque industrial itabo haina; ni; san cristobal NI ; DR NI
• Manufacturer Contact: julie thomas ; johnson & johnson consumer inc; 199 grandview road; skillman, NJ 08558 ; 9082557895
• MDR Report Key: 5093658
• MDR Text Key: 26653607
• Report Number: 8041101-2015-00030
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/25/2015

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: 8137009213
• Device Lot Number: 3174D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Removal/Correction Number: NI
• Patient Sequence Number: 1