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

Device Problem Product Quality Problem (1506)

Patient Problem Choking (2464)

Event Date 08/17/2022

Event Type  Injury  

Event Description

Resulting in choking; as my spouse is having a feeling that the bristles may be stuck in her throat [choking].She did swallow some bristles probably [foreign body ingestion].Case description: this case was reported by a consumer via call center representative and described the occurrence of choking in a 39-year-old female patient who received gsk toothbrush (sensodyne sensitive toothbrush) toothbrush for product used for unknown indication.This case was associated with a product complaint.On (b)(6) 2022, the patient started sensodyne sensitive toothbrush at an unknown dose and frequency.On (b)(6) 2022, less than a day after starting sensodyne sensitive toothbrush, the patient experienced choking (serious criteria gsk medically significant), foreign body ingestion and product complaint.The action taken with sensodyne sensitive toothbrush was unknown.On (b)(6) 2022, the outcome of the choking and foreign body ingestion were recovered/resolved.On an unknown date, the outcome of the product complaint was unknown.The reporter considered the choking and foreign body ingestion to be related to sensodyne sensitive 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: adverse event information was received by a consumer via call center representative (email) on (b)(6) 2022.The consumer stated that "i am a regular customer of your oral products like toothpaste and toothbrush for a long time.Last day ((b)(6) 2022) i bought a set of sensodyne sensitive toothbrushes.Today, while using one of the toothbrushes, a whole set of bristles came off the brush, resulting in choking.As my spouse is having a feeling that the bristles may be stuck in her throat, i took her to a doctor early in the morning.It was an uneasy morning for me as well.As for my spouse.If you want the faulty pc, let me know i will keep it with me for 3 days starting today.I will dispose of it after 3rd day.Invoice details and brush packaging details are attached to the mail along with some photographs.Make sure you are taking some action on this subject and let me know." name of product quality complaint: (b)(4).Adverse event information was received by a consumer via call center representative (inbound call) on (b)(6) 2022."the brush has been used only by my spouse, and not me.I have taken her to the doctor.She is fine now.She did swallow some bristles probably, but she is fine now.She went to work.I cannot see the expiry date or lot number anywhere on the product and packaging.Yes, i can send the defected product back if required but you guys should refund me".Follow up information was received on 24aug2022 from quality assurance department regarding complaint (b)(4) for unknown lot number.Investigation evaluation: 1.Complaint sample is not available, packaging batch can be seen in the photographs provided, ''04/22 s''.Production records of this batch shows that this batch was produced according to the specification and no deviations have been observed.2.Photographs shows one tuft hole without bristles, which came out of the tuft hole along with anchor wire while brushing the teeth.Anchor wire impression can be seen on the tuft hole, which shows that the bristles were tufted with anchor wire.The bristles and anchor wire might have pulled out due to excessive force used by consumer while brushing.3.The brush has been already used by the consumer and we do not know whether consumer has used it in a normal way or not.So without complaint sample it is not possible to investigate and amp; find out the actual root cause of the complaint.The investigation reports concluded that the complaint as inconclusive.The pqc number was (b)(4).

Manufacturer Narrative

Argus case: (b)(4).

• Brand Name: SENSODYNE SENSITIVE 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: 15368892
• MDR Text Key: 299362714
• Report Number: 9615008-2022-00005
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• 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
• Date Manufacturer Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 39 YR
• Patient Sex: Female