MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-05-30 for AQUAFRESH KIDS TOOTHBRUSH manufactured by M And C Schiffer Gmbh.
[146509493]
Argus case (b)(4). Product quality investigation completed 21 may 2019: issue (b)(4). Sample not received for investigation. The review of manufacturing/packaging batch records is not possible due to the lack of batch number. A trend analysis with same product of complaint subject shows no abnormalities. No recall has been started by this article. Further investigation is not possible without receiving the batch number or complaint sample. On the attached photo it looks like some slight bends of the filaments which could occur when child is chewing on the bristles. For further investigation the sample is needed. Please note that last batch of this item is from 16. 04. 2014 - expiry date 01. 04. 2019 which suggest the shelf life to be expired. 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. Unsubstantiated. No manufacturing error has been detected.
Patient Sequence No: 1, Text Type: N, H10
[146509494]
He was choking [choking]. Bristles were loose and some of them out of his mouth but have no idea how many he has swallowed [accidental device ingestion by a child]. He was gagging [gagging]. Spluttering [infantile spitting up]. Quite some time as he was struggling to breath whilst trying to cough up the bristles that were in his throat [difficulty breathing]. My poor little boy has been crying for quite some time [crying]. Case description: this case was reported by a consumer and described the occurrence of choking in a (b)(6) male patient who received gsk toothbrush (aquafresh kids toothbrush) toothbrush (batch number unk, expiry date unknown) for dental cleaning. This case was associated with a product complaint. Co-suspect products included sodium monofluorophosphate (aquafresh kids toothpaste) toothpaste (batch number unk, expiry date unknown) for dental cleaning. On (b)(6) 2019, the patient started aquafresh kids toothbrush and aquafresh kids toothpaste at an unknown dose and frequency. On (b)(6) 2019, less than a day after starting aquafresh kids toothbrush and 0 min after starting aquafresh kids toothbrush and aquafresh kids toothpaste, the patient experienced choking (serious criteria gsk medically significant), accidental device ingestion by a child (serious criteria gsk medically significant), gagging, infantile spitting up, difficulty breathing and crying. On an unknown date, the patient experienced product complaint. The action taken with aquafresh kids toothbrush was unknown. The action taken with aquafresh kids toothpaste was unknown. On an unknown date, the outcome of the choking, accidental device ingestion by a child, gagging, infantile spitting up, difficulty breathing, crying and product complaint were unknown. It was unknown if the reporter considered the choking, accidental device ingestion by a child, gagging, infantile spitting up, difficulty breathing and crying to be related to aquafresh kids toothbrush and aquafresh kids toothpaste. It was unknown if the reporter considered the product complaint to be related to aquafresh kids toothpaste. Additional details: adverse event information was received via email on (b)(6) 2019. The consumer reported that "we as a family have been excited about our son's first teeth brushing. Bought him an 'aquafresh' tooth brush and tooth paste (he's (b)(6) so bought the age appropriate brush and paste) only to be completely horrified when we brushed his teeth for the first time tonight; as with in second he was gagging and spluttering. The bristles were loose in his mouth and some had travelled to the back of his mouth although we only very gently brushed his front teeth, he was choking! I managed to get some of them out of his mouth but have no idea how many he has swallowed. I am appealed that such a 'reliable' company would manufacture something of such poor and dangerous quality! I have attached a picture of what i managed to get out of his mouth which, during his first very gentle tooth brushing experience resulted in a horrific fingers in mouth panicked experience. As a family we were very upset, obviously and my poor little boy has been crying for quite some time as he was struggling to breathe whilst trying to cough up the bristles that were in his throat". Follow up information was received on 21 may 2019 from quality assurance (qa) department regarding complaint number (b)(4) (issue number) for unknown lot number and expiry date. The sample was not received for the investigation. 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. This complaint was unsubstantiated. No manufacturing error has been detected. The initial and follow up information was included in above narrative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615008-2019-00005 |
| MDR Report Key | 8654251 |
| Report Source | CONSUMER |
| Date Received | 2019-05-30 |
| Date of Report | 2019-05-17 |
| Date of Event | 2019-05-17 |
| Date Mfgr Received | 2019-05-17 |
| Date Added to Maude | 2019-05-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | PO BOX 13398 RESEARCH TRIANGLE PARK |
| Manufacturer City | NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 8888255249 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AQUAFRESH KIDS TOOTHBRUSH |
| Generic Name | TOOTHBRUSHES |
| Product Code | EFW |
| Date Received | 2019-05-30 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | M AND C SCHIFFER GMBH |
| Manufacturer Address | NEUSTADT/WIED, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-30 |