MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORAL-B SENSITIVE OR PRECISION CLEAN BRUSHHEADS; TOOTHBRUSH HEAD REFILL

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Vomiting (2144); Choking (2464); Foreign Body In Patient (2687)

Event Type  malfunction  

Event Description

Threw up blood [haematemesis].Choking.Vomiting.Throat sore [oropharyngeal pain].(b)(6) swallowed circle piece from brushhead [exposure via ingestion].Brushhead fell off [device breakage].Case description: a mother reported that her (b)(6) son was using his oral-b professional care 1000 rechargeable toothbrush on (b)(6) 2015 when the oral-b precision clean brushhead popped off.She reported that her son choked on it and swallowed it and it was currently in his stomach; she clarified that he swallowed just the circle piece, but the neck and the toothbrush handle were remaining.She attempted to get him to throw up by putting her finger down his throat, and he did throw up blood.She stated that she telephoned his doctor who informed her that the piece should pass through.Her son developed a sore throat from the choking and vomiting, and woke up on (b)(6) 2015 with his throat still sore.She stated that the brushhead had only been in use for a few months, and that she was not sure if it had ever been dropped.Prod use had been discontinued.The case outcome was improved.Other relevant history: allergies- none, medical history- none.No further info was provided.On (b)(6) 2015 rec'd drug and poison info ctr's f/u phone call with consumer: the mother reported that her son did have a bowel movement, but that he still had not passed the plastic piece.She noted that he was doing okay, but still complained of a sore throat.Per the mother's report, her son's doctor told them to wait 24-48 hours to see if the piece passes and to f/u with him if it did not; she stated the she planned to f/u with him.The case outcome remained improved.No further info was provided.

Manufacturer Narrative

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

• Brand Name: ORAL-B SENSITIVE OR PRECISION CLEAN BRUSHHEADS
• Type of Device: TOOTHBRUSH HEAD REFILL
• Manufacturer (Section D): BRAUN GMBH WERK MARKTHEIDENFELD; marktheidnfeld ; GM
• Manufacturer (Section G): ORAL-B IRELAND; green rd; newbridge, co kildare ; EI
• Manufacturer Contact: mgr ; 8700 mason-montgomery rd; mason business ctr; mason, OH 45040
• MDR Report Key: 4730782
• MDR Text Key: 5739981
• Report Number: 3000302531-2015-00143
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Type of Report: Initial
• Report Date: 03/11/2015

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/11/2015
• Initial Date FDA Received: 04/10/2015
• 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
• Patient Age: 8 YR