MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORAL-B PRECISION CLEAN BRUSHHEADS; TOOTHBRUSH, POWERED

Lot Number H733

Device Problems Crack (1135); Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Reporter returned an unspecified number of toothbrush heads on 05-jan-2017.Product investigation not yet initiated.

Event Description

Precision clean refill cracked and became loose in mouth [device breakage].No adverse event [no adverse event].Case description: a husband reported via phone on (b)(6) 2016 that his wife of unspecified age used an oral-b precision clean brushhead and it cracked and became loose in her mouth.This was not the first time that she had used these particular brush heads.No symptoms developed.Concomitant product: oral-b rechargeable toothbrush, version unknown.

Manufacturer Narrative

From 07-feb-2017 product investigation results: reporter returned an unspecified number of toothbrush heads on (b)(6) 2017.Toothbrush heads confirmed to be counterfeit.

Event Description

Precision clean refill cracked and became loose in mouth [device breakage]; no adverse event [no adverse event]; product counterfeit [product counterfeit].Case description: a husband reported via phone on (b)(6) 2016 that his wife of unspecified age used an oral-b precision clean brushhead and it cracked and became loose in her mouth.This was not the first time that she had used these particular brush heads.No symptoms developed.Concomitant product: oral-b rechargeable toothbrush, version unknown.

• Brand Name: ORAL-B PRECISION CLEAN BRUSHHEADS
• Type of Device: TOOTHBRUSH, POWERED
• Manufacturer (Section D): BRAUN GMBH WERK MARKTHEIDENFELD; 40 baumhofstrasse; marktheidenfeld, D-978 28; GM D-97828
• Manufacturer Contact: regulatory oral care ; 8700 mason montgomery road; mason, OH 45040
• MDR Report Key: 6228225
• MDR Text Key: 64435540
• Report Number: 3000302531-2017-00008
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 12/09/2016

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 Lot Number: H733
• Other Device ID Number: NOT AVAILABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2016
• Initial Date FDA Received: 01/06/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN