MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN; TOOTHBRUSH, POWERED

Device Problems Break (1069); 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 returned product.

Event Description

Brush kept catching on my tongue and nipping it (painfully) / hooking on the sides of my (mouth) and tongue [tongue injury]; brush kept catching on my tongue and (nipping) it painfully [glossodynia]; hooking on the sides of my mouth [mouth injury]; brush kept catching on my tongue and nipping it painfully / hooking on the sides of my mouth and tongue [injury associated with device]; brush was coming loose from the stalk [device breakage]; heads seem to be loose [device connection issue].Case description: a (b)(6) consumer of unspecified gender reported that he or she had been using an oral-b rechargeable toothbrush, version unknown and had recently noticed that the oral-b brushhead, version unknown kept catching on his or her tongue and nipping it painfully.The consumer described that after further examination, he or she found that the brush was coming loose from the "stalk".The case outcome was unknown.No further information was provided.(b)(6) 2015 received follow-up e-mail from consumer: the consumer reported that he or she began using another oral-b brushhead, version unknown and noted that it was doing the same thing that the first brushhead had done with regards to hooking on the sides of his or her mouth and tongue.The consumer stated that the brushheads seemed to be loose and one was making a noise.The case outcome remained unknown.No further information was provided.

Manufacturer Narrative

09-oct-2015 product investigation results: reporter returned 1 toothbrush head used with suspect handle.Toothbrush head confirmed to be counterfeit.

Event Description

Brush kept catching on my tongue and nipping it (painfully) / hooking on the sides of my (mouth) and tongue [tongue injury].Brush kept catching on my tongue and (nipping) it painfully [glossodynia].Hooking on the sides of my mouth [mouth injury].Brush kept catching on my tongue and nipping it painfully / hooking on the sides of my mouth and tongue [injury associated with device].Brush was coming loose from the stalk [device breakage].Heads seem to be loose [device connection issue].Case description: a (b)(6) year old consumer of unspecified gender reported that he or she had been using an oral-b rechargeable toothbrush, version unknown and had recently noticed that the oral-b brushhead, version unknown kept catching on his or her tongue and nipping it painfully.The consumer described that after further examination, he or she found that the brush was coming loose from the "stalk".The case outcome was unknown.No further information was provided.(b)(6) 2015 received follow-up e-mail from consumer: the consumer reported that he or she began using another oral-b brushhead, version unknown and noted that it was doing the same thing that the first brushhead had done with regards to hooking on the sides of his or her mouth and tongue.The consumer stated that the brushhead seemed to be loose and one was making a noise.The case outcome remained unknown.No further information was provided.(b)(6) 2015 received follow-up phone call from consumer: the consumer reported that this was the first time this had happened to her and she stated that she used the product daily.The pain-tongue started immediately after she used the product but had recovered within a few hours.She had discontinued use of the product.The case outcome was improved.Other relevant history: allergies- none.No further information was provided.(b)(6) 2015 received follow-up email from consumer: the concomitant brush heads used were identified as oral-b precision clean brushhead eb20.No further information was provided.09-oct-2015 product investigation results: the suspect handle in this case was used with a toothbrush head that was confirmed to be counterfeit.

• Brand Name: ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN
• 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: 5067849
• MDR Text Key: 26040637
• Report Number: 3000302531-2015-00284
• 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
• Report Date: 08/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2015
• 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
• Patient Age: 43 YR