MAUDE Adverse Event Report: M + C SCHIFFER GMBH DR BEST ZWISCHENZAHN; TOOTHBRUSHES

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problems Injury (2348); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

The 9615008-2016-00002 is associated with argus (b)(6), dr best zwischenzahn.Dr best zwischenzahn is marketed as sensodyne toothbrush in the us.

Event Description

Pharynx injured [pharyngeal injury].Bristles stuck in throat [foreign body].Product complaint [product complaint].Case description: this case was reported by a consumer via call center representative and described the occurrence of pharyngeal injury in a male patient who received gsk toothbrush (dr best zwischenzahn) toothbrush for drug use for unknown indication.In (b)(6) 2015, the patient started dr best zwischenzahn.On an unknown date, an unknown time after starting dr best zwischenzahn, the patient experienced pharyngeal injury (serious criteria gsk medically significant), foreign body and product complaint.The action taken with dr best zwischenzahn was unknown.On an unknown date, the outcome of the pharyngeal injury and foreign body were not reported and the outcome of the product complaint was unknown.It was unknown if the reporter considered the pharyngeal injury and foreign body to be related to dr best zwischenzahn.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: the patient used dr.Best toothbrushes for years and was satisfied with them.The bristles fell out of the toothbrush and stuck in throat.Pharynx was injured by the bristles and the patient had to consult an otolaryngologist.

Event Description

Case description: this case was reported by a consumer via call center representative and described the occurrence of pharyngeal injury in a male patient who received gsk toothbrush (dr best zwischenzahn) toothbrush for drug use for unknown indication.In (b)(6) 2015, the patient started dr best zwischenzahn.On an unknown date, an unknown time after starting dr best zwischenzahn, the patient experienced pharyngeal injury (serious criteria gsk medically significant), foreign body and product complaint.The action taken with dr best zwischenzahn was unknown.On an unknown date, the outcome of the pharyngeal injury and foreign body were not reported and the outcome of the product complaint was unknown.It was unknown if the reporter considered the pharyngeal injury and foreign body to be related to dr best zwischenzahn.Additional details: the patient used dr.Best toothbrushes for years and was satisfied with them.The bristles fell out of the toothbrush and stuck in throat.Pharynx was injured by the bristles and the patient had to consult an otolaryngologist.Follow up information received on 18th january 2016 after using dr best zwischenzahn for 2 weeks, the bristles fell out and got stuck in his throat.Dr best zwischenzahn was withdrawn on an unknown date after use for approximately 14 days (dechallenge was unknown).

• Brand Name: DR BEST ZWISCHENZAHN
• Type of Device: TOOTHBRUSHES
• Manufacturer (Section D): M + C SCHIFFER GMBH; industriestrasse 4 neustadt/wi; germany 53577 ; GM 53577
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 5374983
• MDR Text Key: 36233184
• Report Number: 9615008-2016-00002
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: 01/05/2016
• Initial Date FDA Received: 01/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other