MAUDE Adverse Event Report: ENURESIS SOLUTIONS LLC DRYBUDDYEZ; BEDWETTING ALARM

Model Number DRYBUDDYEZ

Device Problems Device Unsafe to Use in Environment (2918); Manufacturing, Packaging or Shipping Problem (2975); No Fail-Safe Mechanism (2990)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/15/2015

Event Type  Injury  

Event Description

These alarms are marketed to children under 3 years of age as potty training products with no age guideline on the packaging.The alarm cables contain very high levels of the phthalate dinp which is 200 times higher than what is allowed by cpsc.The cable is under 5cm on one side and can easily be placed in a child's mouth.Also the battery door is a small part which can cause choking hazard in children.The dry defender bedding is sold with no certificate or lot number and very high levels of phthalate dinp.Neither of these products has documentation and/or tracebility possible although they have been selling for years.Purchase date: (b)(6) 2015.

Event Description

Add'l info received on 11/16/2015: the intent of this complaint is to report malem bedwetting alarms and other products sold by the company (b)(4), which violate and fail several fda requirements.Malem alarms are sold exclusively in the usa by (b)(4) associates through their website (b)(4) and many other sites.These alarms have labeling, mechanical, chemical and other non-conformities.Alarms fail the following: astm f 963-11 standard for small objects, astm f 963-11 standard for accessible, astm f 963-11 standard for cords and elastics in toys, marking and instructions, exceeding phthalates, high content of mercury and bromine, marketing to children under 3 without document malem bedwetting alarms are marketed and sold to families as bedwetting alarms as well as potty training tools for children as low as age 1.5 years.Certified cpsc lab reports show that the product contains small parts which can cause a chocking hazard.The product does not have necessary elements: lot number, age guidelines, country of origin, contact info for mfr, support etc.The cable contains unusually high amounts of phthalate dinp (200 x more than mandated by cpsc for articles which can be placed in a child's mouth).Product contains high levels of bromine and mercury and lead.Company has not done due diligence regarding an adequate risk-assessment/hazard assessment (as required) and continues to market products to children under age 3 with no consideration or value of lives.Company has failed so many tests that the product may be unsafe for use.It is estimated that there are over (b)(4) malem alarms in the market today.Company also sells a waterproof bedding with no tags and the bedding contains 9 times more phthalate dinp than mandated by law.

Event Description

Add'l info received from reporter on 11/18/2015.The intent of this complaint is to report a brand of products sold in the usa market which violate and fail several fda requirements.The products are the dry buddy bedwetting alarms and other products sold by the company enuresis solutions, llc through their website www/drybuddy.Com.Drybuddy alarms called out in this report are manufactured and sold in the usa by enuresis solutions through their website www.Drybuddy.Com and many other (related/affiliated) sites.These alarms have labeling, mechanical, chemical and other non-conformities, with at least: astm f 963-11 standard for small objects; astm f 963-11 standard for accessible points; astm f 963-11 standard for cords and elastics in toys; marking and instructions; exceeding phthalates (dehp) which is banned by cpsc for children's products); marketing products to children under age 3 years without correct documentation; the main areas of non-conformity of concern to the fda is failure to register contract mfr shenzhen poshton technology co., ltd, (b)(4) since 2005; marketing products to children without correct age recommendation/guidance; absence of lot number (lack of traceability); lack of the due diligence regarding an adequate risk-assessment/hazard assessment (as required); claims that product "cures bedwetting permanently" without dangerous medication; false claims that product is certified for sale in (b)(6) and product is manufactured in iso 13485 compliant factory (no record of this can be found).

Event Description

Add'l info received on 11/18/2015: the intent of this complaint is to report a brand of products sold in the usa market which violate and fail several child safety requirements.The products are the dry buddy bedwetting alarms and other product sold by the company (b)(4) through their website (b)(4).Drybuddy alarms called out in this report are manufactured and sold in the usa by (b)(4), through their website (b)(4) and many other (related/affiliated) sites.These alarms have labeling, mechanical, chemical and other non-conformities, with at least: astm f 963-11 standard for small objects; astm f 963-11 standard for accessible points; astm f 963-11 standard for cords and elastics in toys; marking and instructions; exceeding phthalates (dehp which is banned by cpsc for childrens products); marketing products to children under age 3 years without correct documentation; failure to register contract mfr (b)(4) since 2005; marketing products to children without correct age recommendation/guidance; absence of lot # (lack of traceability); lack of due diligence regarding an adequate risk-assessment/hazard assessment (as required); false claims that product is certified for sale in (b)(6) and product is manufactured in iso 13485 complaint factory (no record of this can be found).Testing for these samples were conducted by a cspc accredited lab - (b)(6) worldwide standards and testing company limited.The lab details are at: http://www.Cpsc.Gov/cgi-bin/labsearch/viewlab.Aspx?labid=1015.There are other concerns that might very well be of interest/concern with the epa and osha (via the nrtl product safety program).It is the opinion of this report that these alarms and mats expose children to significant safety hazards including toxic chemicals, small parts and more regarding the safety of children, these products should be recalled from the market, until safer designs can be implemented.Add'l event date: (b)(6) 2015.Document number: (b)(4).

Event Description

Add'l info received from reporter on 05/24/2016.This complaint is to report the complete line of malem bedwetting alarms and other products sold in usa exclusively by (b)(4).These children's products violate and fail several child safety requirements including marketing to children without correct age guidelines, absence of lot number, lack of risk assessment and small parts which can cause chocking.These products have mechanical, chemical and other safety concerns, which are out of conformity for: marketing products to children without correct age recommendation/guidance; absence of lot number (lack of traceability); lack of due diligence regarding an adequate risk-assessment/hazard assessment (as required); chocking hazard for children due to small parts.(b)(4) is the importer of record and details are (b)(4).Is the mfr of the product in (b)(4).I purchased several samples of the product at two separate times, in a span of over 6 months to get them tested.Both reports show that the product fails many requirements for sale to children.The second report shows that the products contain high levels of the (b)(4).

Event Description

Additional information received from reporter (b)(6) 2016.Several months ago, i have complained to the fda about a brand of (b)(4) alarms (class ii devices) sold in the usa.These products are manufactured and sold by (b)(4).These alarms have mechanical, chemical and other safety concerns, all of which seem to be clearly out of conformity with at least: marketing products to children without correct age recommendation/guidance; absence of lot # (lack of traceability); lack of due diligence regarding an adequate risk-assessment/hazard assessment (as required); choking hazard for children due to small parts.As well as these related standards the manufacture failed to design for (against) as per the risk assessment requirements: (b)(4) standard for small objects; (b)(4)standard for accessible points; (b)(4) standard for cords and elastics in (b)(4); marking and instructions; exceeding phthalates - dhep; high content of mercury; high content of bromine; marketing products to children under age 3 years without correct documentation.I have tested these products at a (b)(4) certified lab - (b)(4) worldwide standards and testing company limited.The lab details are at: (b)(4).I purchased several samples of the product at two separate times, in a span of over 6 months to get them tested.Both reports show that the product fails many requirements for sale to children.The attached report shows that the products contain high levels of the phthalate dehp which is banned by the (b)(4).The reports show that these devices expose children to significant product safety hazards including toxic chemicals, small parts and more.It is the opinion of this report that for the safety of children, these products be recalled from the market, until a safer design can be implemented.

• Brand Name: DRYBUDDYEZ
• Type of Device: BEDWETTING ALARM
• Manufacturer (Section D): ENURESIS SOLUTIONS LLC; 51 w fairmont ave ste 2; savannah GA 31406
• MDR Report Key: 5201344
• MDR Text Key: 30489381
• Report Number: MW5057658
• Device Sequence Number: 1
• Product Code: KPN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/09/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DRYBUDDYEZ
• Device Catalogue Number: NONE
• Device Lot Number: NONE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 33 MO