MAUDE Adverse Event Report: M AND C SCHIFFER GMBH SENSODYNE TOOTHBRUSH; TOOTHBRUSHES

Lot Number 061120080 S431PAL5704

Device Problem Product Quality Problem (1506)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

Device swallow [accidental device ingestion].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a patient who received gsk toothbrush (sensodyne toothbrush) toothbrush (batch number 061120080 s431pal5704, expiry date unknown) for drug use for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started sensodyne toothbrush.On an unknown date, an unknown time after starting sensodyne toothbrush, the patient experienced accidental device ingestion (serious criteria gsk medically significant) and product complaint.The action taken with sensodyne toothbrush was unknown.On an unknown date, the outcome of the accidental device ingestion and product complaint were unknown.It was unknown if the reporter considered the accidental device ingestion to be related to sensodyne toothbrush.This report is made by gsk/haleon without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details:the adverse event information was received from consumer via call center representative (phone) on 05oct2022 and consumer reported that "we bought a sensodyne toothbrush, it's soft, pink, we bought it for my daughter, bristels come out when we brush, it even comes into our mouths, we may have swallowed it.Full product name and variant: sensodyne soft toothbrush for sensitive teeth.Product size lot/lot no 061120080 s431pal5704 expiry date not written on the bristles of the toothbrush break off when brushing teeth during use and stay in our mouth.We used another toothpaste before, we did not have such a problem.Our fear is our child is also using this sensodyne toothbrush.I hope he didn't swallow the bristles.If you have a problem with your toothbrushes, i would appreciate it if you let me know.Good work".This case is 1 of 2 from the same reporter.Case (b)(4) is a reporter reporting for reporter and other person.Cases (b)(4)(reporter's case) and (b)(4) (case for other person) are created.Please see case (b)(4).

• Brand Name: SENSODYNE TOOTHBRUSH
• Type of Device: TOOTHBRUSHES
• Manufacturer (Section D): M AND C SCHIFFER GMBH; neustadt/weid, ; GM
• Manufacturer Contact: 184 liberty corner road; suite 200; warren, NJ 07059 ; 8888255249
• MDR Report Key: 15426437
• MDR Text Key: 299935513
• Report Number: 9615008-2022-00006
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 061120080 S431PAL5704
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/05/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other