MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRPWRORALCARERFLSPRECISIONCLEAN; TOOTHBRUSH, POWERED

Lot Number NOT AVAILABLE

Device Problems Break (1069); Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Return of product has been requested.Product and lot number not provided by the reporter therefore unable to proceed with product investigation at this time.Full evaluation will occur upon receipt of returned product.

Event Description

Had 3 brush heads break in a row / faulty brush head / brush head developed play between brush and stem, visible cracking damage at back of brush head [device breakage]; no adverse event [no adverse event].Case description: a female consumer of unspecified age reported via phone on (b)(6) 2017 that she had 3 oral-b power oral care refills precision clean break in a row.This was not the first time that she had used these particular brush heads, and she'd never had problems before.She carried out the scratch test, and the brush head passed.One brush of the 3 out of the first pack of brush heads was faulty, and she had 2 unopened packs out of the same set that she bought.No symptoms developed.Concomitant product: oral-b rechargeable toothbrush, version unknown.On 12-apr-2017 received consumer's follow-up phone call: the consumer reported that the brush head developed play between the brush and stem, and there was visible cracking damage at the back of the brush head.No further information was provided.

Manufacturer Narrative

On 05-may-2017 product investigation results: reporter returned 3 toothbrush heads on 25-apr-2017.Toothbrush heads confirmed to be counterfeit.

Event Description

Had 3 brush heads break in a row / faulty brush head / brush head developed play between brush and stem, visible cracking damage at back of brush head.Product counterfeit.Case description: a female consumer of unspecified age reported via phone on 27-mar-2017 that she had 3 oral-b power oral care refills precision clean break in a row.This was not the first time that she had used these particular brush heads, and she'd never had problems before.She carried out the scratch test, and the brush head passed.One brush of the 3 out of the first pack of brush heads was faulty, and she had 2 unopened packs out of the same set that she bought.No symptoms developed.Concomitant product: oral-b rechargeable toothbrush, version unknown.On 12-apr-2017 received consumer's follow-up phone call: the consumer reported that the brush head developed play between the brush and stem, and there was visible cracking damage at the back of the brush head.No further information was provided.

• Brand Name: ORALBPWRPWRORALCARERFLSPRECISIONCLEAN
• 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: 6519175
• MDR Text Key: 74014987
• Report Number: 3000302531-2017-00167
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 03/27/2017

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: NOT AVAILABLE
• Other Device ID Number: NOT AVAILABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2017
• Initial Date FDA Received: 04/25/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2017
• 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