MAUDE Adverse Event Report: M AND C SCHIFFER GMBH DR. BEST POLIMED MEDIUM; TOOTHBRUSHES

Device Problem Product Quality Problem (1506)

Patient Problems No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

The bristles dissipated in the throat [foreign body in throat].Case description: this case was reported by a consumer via call center representative and described the occurrence of foreign body in throat in a male patient who received gsk toothbrush (dr.Best polimed medium) toothbrush for oral hygiene.This case was associated with a product complaint.On an unknown date, the patient started dr.Best polimed medium at an unknown dose and frequency.On an unknown date, an unknown time after starting dr.(b)(6) polimed medium, the patient experienced foreign body in throat (serious criteria gsk medically significant) and product complaint.The action taken with dr.Best polimed medium was unknown.On an unknown date, the outcome of the foreign body in throat and product complaint were unknown.It was unknown if the reporter considered the foreign body in throat to be related to dr.Best polimed medium.Additional details: it was reported that the bristles dissipated in the throat.Follow up information was received from quality assurance department on 15may 2020: due to missing information like no lot or no sample hub agent closed the case.

Event Description

Case description: this case was reported by a consumer via call center representative and described the occurrence of foreign body in throat in a male patient who received gsk toothbrush (dr.Best polimed medium) toothbrush for oral hygiene.This case was associated with a product complaint.On an unknown date, the patient started dr.Best polimed medium at an unknown dose and frequency.On an unknown date, an unknown time after starting dr.Best polimed medium, the patient experienced foreign body in throat (serious criteria gsk medically significant) and product complaint.The action taken with dr.Best polimed medium was unknown.On an unknown date, the outcome of the foreign body in throat and product complaint were unknown.It was unknown if the reporter considered the foreign body in throat to be related to dr.Best polimed medium.Additional details: it was reported that the bristles dissipated in the throat.Follow up information was received from quality assurance department on 15may 2020: due to missing information like no lot or no sample hub agent closed the case.Follow up information was received on 24mar2023 from quality assurance (qa) department regarding product quality complaint with case number (b)(4) for unknown lot number.Investigation evaluation: status update: reopened on 22mar2023, loc qa triaged.Site identified from case review.Case to be sent to site for investigation.No samples to be requested during triage.No sample was returned for this complaint and the lot/batch details were not received so a full investigation cannot be completed.As this information is not available the complaint cannot be substantiated and will be closed as inconclusive.If the consumer contacts us with additional information or if the complaint sample is received, the complaint issue will be reopened and further evaluated.2023-03-24 12:12:59: complaint response (b)(4) condition of complaint sample(s), description of complaint classification : critical reciept sample: schiffer didn't receive the sample for investigation, yet.Consumer verbatim: 'beim ersten gebrauch von dr.Best polimed (mittel) sind sind die borsten im hals aufgelöst.' notice : the following details assume that it is product of schiffer.Root cause analysis the review of manufacturing / packaging batch records is not possible due to the lack of toothbrush/packaging batch number.Further investigation is not possible without receiving the batch number or complaint sample.This complaint has been logged and will be evaluated and present in the monthly complaint review process.On the basis of the above the complaint is considered as closed.With the receipt of the complaint sample, the complaint will be re-opened and further investigation carried out as required.A final report will be issued in accordance with the quality agreement within 30 days after receiving the complaint sample.Response to consumer: no sample was returned for this complaint, also batch details were not received so a full investigation could not be completed.As this information is not available the complaint cannot be substantiated.All of the documentation pertinent to a specific lot of finished product is contained in a [?]batch envelope'.Prior to the disposition of the product, the contents of each batch envelope is reviewed and approved by the site quality department to verify that there were no significant quality issues recorded during manufacturing, packaging or testing.This review also verifies that all test results meet specification requirements.The investigation reports concluded that, complaint stands unsubstantiated.The pqc number was reported as (b)(4).Case correction performed to the initially processed report received on 13may2020.No therapy was added as concomitant.Causality for event foreign body in throat was updated to yes.The statement 'this report is made by gsk/haleon without prejudice and does not imply any admission or liability for the incident or its consequences' was added.Follow up information was received on 28mar2023 from quality assurance (qa) department regarding complaint b)(4) for unknown lot number.No new information was updated to the case.

Manufacturer Narrative

Argus case id: (b)(4).

• Brand Name: DR. BEST POLIMED MEDIUM
• Type of Device: TOOTHBRUSHES
• Manufacturer (Section D): M AND C SCHIFFER GMBH; m and c schiffer gmbh; neustadt/weid, ; GM
• Manufacturer Contact: 184 liberty corner road; suite 200; warren,, TN 07059 ; 8888255249
• MDR Report Key: 10114320
• MDR Text Key: 200206072
• Report Number: 9615008-2020-00002
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• 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: 03/24/2023
• 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
• Treatment: 1) NO THERAPY (NO THERAPY)
• Patient Outcome(s): Other
• Patient Sex: Male