MAUDE Adverse Event Report: M AND C SCHIFFER GMBH DR BEST ERSTE ZAEHNE; GSK TOOTHBRUSH

Lot Number S0044702S B

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

Probably had to fight with other loose bristles that irritated her throat [foreign body in throat].Constantly trying to clear her throat/irritated throat [throat irritation].Coughed terribly and i could hardly calm her down [cough].Case description: this case was reported by a consumer via call center representative and described the occurrence of foreign body in throat in a (b)(6)-old female patient who received gsk toothbrush (dr best erste zaehne) toothbrush for product used for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started dr best erste zaehne at an unknown dose and frequency.On an unknown date, an unknown time after starting dr best erste zaehne, the patient experienced foreign body in throat (serious criteria gsk medically significant), throat irritation, cough and product complaint.The action taken with dr best erste zaehne was unknown.On an unknown date, the outcome of the foreign body in throat, throat irritation, cough and product complaint were unknown.It was unknown if the reporter considered the foreign body in throat, throat irritation and cough to be related to dr best erste zaehne.Additional details: consumer reported consumer brushed (b)(6) old daughter's teeth in the evening with a new toothbrush.The brush was used for the first time.When consumer's daughter finished brushing , 3 bristles stood very far.Consumer could just pull them out with the teeth without any resistance.When consumer breastfed consumer's daughter afterwards, daughter coughed terribly and consumer could hardly calm her down.Consumer had been constantly trying to clear daughter's throat.Probably had to fight with other loose bristles that irritated her throat.,such quality defects it was irresponsible to offer a product for 0-2 years.A (b)(6) old baby could had suffocated.Follow up information received on 25-may-2020: no new medically significant information was received.Follow up information was received form qa department on 29 may 2020: qa result revealed product complaint to be unsubstantiated.

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 11-month-old female patient who received gsk toothbrush (dr best erste zaehne) toothbrush for product used for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started dr best erste zaehne at an unknown dose and frequency.On an unknown date, an unknown time after starting dr best erste zaehne, the patient experienced foreign body in throat (serious criteria gsk medically significant), throat irritation, cough and product complaint.The action taken with dr best erste zaehne was unknown.On an unknown date, the outcome of the foreign body in throat, throat irritation, cough and product complaint were unknown.It was unknown if the reporter considered the foreign body in throat, throat irritation and cough to be related to dr best erste zaehne.Additional details: consumer reported consumer brushed 11 month old daughter's teeth in the evening with a new toothbrush.The brush was used for the first time.When consumer's daughter finished brushing, 3 bristles stood very far.Consumer could just pull them out with the teeth without any resistance.When consumer breastfed consumer's daughter afterwards, daughter coughed terribly and consumer could hardly calm her down.Consumer had been constantly trying to clear daughter's throat.Probably had to fight with other loose bristles that irritated her throat.,such quality defects it was irresponsible to offer a product for 0-2 years.A 2-week old baby could had suffocated.Follow up information received on 25-may-2020: no new medically significant information was received.Follow up information was received form qa department on 29 may 2020: qa result revealed product complaint to be unsubstantiated.Follow up information was received on 10 jun 2020 from quality assurance (qa) department regarding complaint (b)(4) for s0044702s b lot number.The analysis included visual and microscopic inspection, view of product review.Product was monitored and documented by production control in each shift.Deviations were not documented.The inspection showed traces of squeezes at the filaments and some sticking filaments, head back were slightly damaged.The damage at the filaments was obviously caused by biting on the filaments of toothbrush.Individual filaments of a bundle could thus be extracted during the brushing.Review of relevant manufacturing / packaging batch records were done.The toothbrush was manufactured according to current specifications.No recall had been started by this article.This complaint was not due to production error.Qa analysis concluded to be unsubstantiated.

Manufacturer Narrative

Argus case id: (b)(4).

Manufacturer Narrative

Argus case (b)(4).

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 11-month-old female patient who received gsk toothbrush (dr best erste zaehne) toothbrush for product used for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started dr best erste zaehne at an unknown dose and frequency.On an unknown date, an unknown time after starting dr best erste zaehne, the patient experienced foreign body in throat (serious criteria gsk medically significant), throat irritation, cough and product complaint.The action taken with dr best erste zaehne was unknown.On an unknown date, the outcome of the foreign body in throat, throat irritation, cough and product complaint were unknown.It was unknown if the reporter considered the foreign body in throat, throat irritation and cough to be related to dr best erste zaehne.Additional details: consumer reported consumer brushed 11 month old daughter's teeth in the evening with a new toothbrush.The brush was used for the first time.When consumer's daughter finished brushing , 3 bristles stood very far.Consumer could just pull them out with the teeth without any resistance.When consumer breastfed consumer's daughter afterwards, daughter coughed terribly and consumer could hardly calm her down.Consumer had been constantly trying to clear daughter's throat.Probably had to fight with other loose bristles that irritated her throat.Such quality defects it was irresponsible to offer a product for 0-2 years.A 2-week old baby could had suffocated.Follow up information received on 25-may-2020: no new medically significant information was received.Follow up information was received form qa department on 29 may 2020: qa result revealed product complaint to be unsubstantiated.Follow up information was received on 10 jun 2020 from quality assurance (qa) department regarding complaint (b)(4) for s0044702s b lot number.The analysis included visual and microscopic inspection, view of product review.Product was monitored and documented by production control in each shift.Deviations were not documented.The inspection showed traces of squeezes at the filaments and some sticking filaments, head back were slightly damaged.The damage at the filaments was obviously caused by biting on the filaments of toothbrush.Individual filaments of a bundle could thus be extracted during the brushing.Review of relevant manufacturing / packaging batch records were done.The toothbrush was manufactured according to current specifications.No recall had been started by this article.This complaint was not due to production error.Qa analysis concluded to be unsubstantiated.Case correction as per information received on 10 jun 2020: medwatch form for product was updated.Follow up information was received on 17 jul 2020 from quality assurance (qa) department regarding complaint (b)(4) for s0044702s b lot number: final quality analysis report was received.Quality assurance analysis revealed the complaint to be unsubstantiated.

• Brand Name: DR BEST ERSTE ZAEHNE
• Type of Device: GSK TOOTHBRUSH
• Manufacturer (Section D): M AND C SCHIFFER GMBH; neustadt/wied, ; GM
• MDR Report Key: 10132369
• MDR Text Key: 195762035
• Report Number: 9615008-2020-00003
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,user facilit
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: S0044702S B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 11 MO