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

Device Problems Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

We may have swallowed it [accidental device ingestion].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 complete care toothbrush) toothbrush for drug use for unknown indication.On an unknown date, the patient started sensodyne complete care toothbrush at an unknown dose and frequency.On an unknown date, an unknown time after starting sensodyne complete care toothbrush, the patient experienced accidental device ingestion (serious criteria gsk medically significant).The action taken with sensodyne complete care toothbrush was unknown.On an unknown date, the outcome of the accidental device ingestion was unknown.It was unknown if the reporter considered the accidental device ingestion to be related to sensodyne complete care toothbrush.Additional details: the adverse event information was received from consumer via call center representative (phone) on 05 sep 2022 and consumer reported that "we bought a sensodyne toothbrush, it's soft, pink,it even comes into our mouths, we may have swallowed it.Full product name and variant 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." this case is 2 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.(b)(4).

Manufacturer Narrative

Argus case: (b)(4).

Event 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 complete care toothbrush) toothbrush for drug use for unknown indication.On an unknown date, the patient started sensodyne complete care toothbrush at an unknown dose and frequency.On an unknown date, an unknown time after starting sensodyne complete care toothbrush, the patient experienced accidental device ingestion (serious criteria gsk medically significant).The action taken with sensodyne complete care toothbrush was unknown.On an unknown date, the outcome of the accidental device ingestion was unknown.It was unknown if the reporter considered the accidental device ingestion to be related to sensodyne complete care toothbrush.Additional details:the adverse event information was received from consumer via call center representative (phone) on 05sep2022 and consumer reported that "we bought a sensodyne toothbrush, it's soft, pink,it even comes into our mouths, we may have swallowed it.Full product name and variant 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." this case is 2 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).Error correction for information received on 05sep2022 and event product complaint was added with causality not applicable.Narrative was added as" 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.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.

Manufacturer Narrative

Argus case: (b)(4).

• Brand Name: SENSODYNE COMPLETE CARE 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: 15426478
• MDR Text Key: 299936235
• Report Number: 9615008-2022-00007
• 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,Followup
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: 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