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

Device Problems Material Separation (1562); Sticking (1597)

Patient Problems Pain (1994); Injury (2348)

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 the returned product.

Event Description

Toothbrush stuck to lip [lip injury]; (toothbrush stuck to) lip which was very painful [lip pain]; toothbrush stuck to my lip which was very painful [injury associated with device]; two iron sticks have come out of the back of brush head; brush head completely; separate from the part it is supposed to be attached to [device breakage].Case description: a female consumer reported that while using an oral-b rechargeable toothbrush, version unknown on an unspecified date in (b)(6) 2016, she felt something strange in her mouth, and found that two iron sticks had come out of the back of the oral-b brushhead, version unknown.The consumer replaced the brush head, and felt something strange around her lips when she used the product on (b)(6) 2016.She reported the entire toothbrush stuck to her lip, which was very painful, during use on (b)(6) 2016, and the brush head was completely separate from the part to which it was supposed to be attached.The case outcome was unknown.

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 the returned product.

Event Description

Toothbrush stuck to lip [lip injury]; (toothbrush stuck to) lip which was very painful [lip pain]; toothbrush stuck to my lip which was very painful [injury associated with device]; two iron sticks have come out of the back of brush head; brush head completely separate from the part it is supposed to be attached to; brush heads broken [device breakage].Case description: a female consumer reported that while using an oral-b rechargeable toothbrush, version unknown on an unspecified date in (b)(6) 2016, she felt something strange in her mouth, and found that two iron sticks had come out of the back of the oral-b brushhead, version unknown.The consumer replaced the brush head, and felt something strange around her lips when she used the product on (b)(6) 2016.She reported the entire toothbrush stuck to her lip, which was very painful, during use on (b)(6) 2016, and the brush head was completely separate from the part to which it was supposed to be attached.The case outcome was unknown.12-apr-2016 received follow-up: the consumer reported that 3 of 4 brush heads had broken.She stated she had just got to the fourth brush head, and she hoped it would work.No further information was provided.17-may-2016 update: based on a product picture submitted by the consumer on (b)(6) 2016, the suspect product was identified as oral-b power oral care refills precision clean.

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 the returned product.

Event Description

Toothbrush stuck to lip [lip injury].(toothbrush stuck to) lip which was very painful [lip pain].Toothbrush stuck to my lip which was very painful [injury associated with device].Two iron sticks have come out of the back of brush head; brush head completely separate from the part it is supposed to be attached to; brush heads broken [device breakage].Case description: a female consumer reported that while using an oral-b rechargeable toothbrush, version unknown on an unspecified date in (b)(6) 2016, she felt something strange in her mouth, and found that two iron sticks had come out of the back of the oral-b brushhead, version unknown.The consumer replaced the brush head, and felt something strange around her lips when she used the product on (b)(6) 2016.She reported the entire toothbrush stuck to her lip, which was very painful, during use on (b)(6) 2016, and the brush head was completely separate from the part to which it was supposed to be attached.The case outcome was unknown.On 12-apr-2016 received follow-up: the consumer reported that 3 of 4 brush heads had broken.She stated she had just got to the fourth brush head, and she hoped it would work.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: 5546798
• MDR Text Key: 42614550
• Report Number: 3000302531-2016-00139
• 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,Followup
• Report Date: 03/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/27/2016
• 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: Reuse
• Patient Sequence Number: 1