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

Lot Number NOT AVAILABLE

Device Problems Break (1069); Microbial Contamination of Device (2303)

Patient Problems Fever (1858); Respiratory Tract Infection (2420)

Event Type  Injury  

Manufacturer Narrative

Product return was requested but not received so far.Full evaluation will occur upon receipt of returned product.

Event Description

Upper respiratory infection [upper respiratory tract infection].Wheezing [wheezing].High temperature [pyrexia].Ill [illness].Coughing [cough].Stuffy nose [nasal congestion].Black mold (mould) in toothbrush [product contamination microbial].Toothbrush snapped - oral b [device breakage].The parent reported spontaneously via e-mail on 08-oct-2018 that his/her child, a (b)(6) year old male, was using oral-b power battery toothbrush handle stages and he was ill for 3 weeks.The parent stated that he/she knocked excess water off into the sink and bits of mold came out.He had the toothbrush for 2 months.Relevant history: none reported.Allergies: none reported.The case outcome was unknown.No further information was provided.08-oct-2018 received follow up: the parent stated that his/her son was using the toothbrush twice a day.No further information was provided.08-oct-2018 received follow up: the parent reported that he was still coughing.He was off school for 2 days and had 2 doctor visits.He was treated with antibiotics.08-oct-2018 received follow up: the parent reported that he was hospitalized overnight and was treated with antibiotics for a week.08-oct-2018 received follow up: the parent reported that he had a very high temperature and visited the doctor on (b)(6) 2018.He was diagnosed with a viral upper respiratory infection.He was wheezing, coughing, and had a stuffy nose.He was home from school at the time.The parent stated that he was still poorly but doing better.Event outcome: ill - remained improved.The overall case outcome was improved.No further information was provided.Follow up date: 2018-10-08 the parent reported that after using the toothbrush, it was rinsed off in water, excess water was knocked off, and then left in an upright position to air dry.The overall case outcome was improved.10-nov-2020 update: a duplicate report (case (b)(4)) was combined with this case where the grandparent reported spontaneously on 08-oct-2018 that his/her grandson had been using oral-b power battery toothbrush handle 3735 stages princess-cars with oral-b power oral care refills kids for a few months.While shaking it off, the circular section of the brush snapped off.They noticed black mold growing inside the product.His/her grandson had been ill.Event outcome: ill - remained improved.The case outcome remained improved.No further information was provided.

• Brand Name: ORALBPWRPWRORALCARERFLSKIDS
• Type of Device: TOOTHBRUSH, POWERED
• Manufacturer (Section D): BRAUN GMBH WERK MARKTHEIDENFELD; 40 baumhofstrasse; marktheidenfeld, D-978 28; GM D-97828
• Manufacturer (Section G): BRAUN GMBH WERK MARKTHEIDENFELD; 40 baumhofstrasse; marktheidenfeld, D-978 28; GM D-97828
• Manufacturer Contact: regulatory oral care ; 8700 mason-montgomery rd; mason, OH 45040
• MDR Report Key: 11010568
• MDR Text Key: 221527007
• Report Number: 3000302531-2020-00234
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/08/2018
• Initial Date FDA Received: 12/15/2020
• 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
• Treatment: ORALBPWRBATTTOOTHBRUSHHANDLE3735STAGESPRINCESSCARS
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 3 YR