[24995888]
Svhc and mechanical hazards compliance violations report. For (b)(4), malem medical line devices, (b)(4) line of bedding. Introduction: the intent of this complaint is to report a brand of products sold in the usa market which seem to violate and fail several requirements. A concerned parent, whose child began to choke on a loose part (a removable battery cover) came to me for assistance (closer inspection). The mother of the child knew i was a long time regulatory compliance professional, and asked me to take a closer look to asses, if any regulations, the device may be non compliant against. I did a deep dive and found a plethora of non-conformities, some of which put children and young children (the age group the devices are marketing as 'to be used by') at great risk. The products in question are the malem bedwetting alarms and other products sold by the company (b)(4). Malem alarms called out in this report are sold exclusively in the usa by (b)(4) and many other (related / affiliated) sites. These alarms have mechanical, chemical and other safety concerns, all of which seem to be clearly out of conformity 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; high content of mercury; high content of bromine; marketing products to children under age 3 years without correct documentation. Testing for these samples was conducted by a cspc certified lab - (b)(4). The lab details are at: http:/ /www. Cpsc. Gov/cgi-bin / labsearch/viewlab. Aspx? Labid=1015. The official test report is included in section 6. In section 7, we have included additional tests performed internally for other products, which show that the complete line of malem product is seriously out of conformance. Additionally, the bedding line carried by enuresis (b)(4) is called dry defender (b)(4). These bed wetting devices do not contain labels, lot numbers and many other essential's for devices intended for use by children. It is my finding that there exists no certification for the bed wetting family of devices. There are other concerns that might very well be of interest /concern with the fda, epa and osha (via the nrtl product safety program). It is the findings of this report, that these alarms expose children to significant safety hazards including toxic chemicals, small parts and more and for the safety of children, these products should be recalled from the market, until a safer design can be implemented. The (b)(4)/malem medical devices. The following excerpts have been taken directly from the (b)(4) and/or malem medical website (www. Malemmedical. Com). Malem enuresis alarms (bedwetting alarms) are designed to maximize success in the treatment and cure of bedwetting and provide a safe, efficient, economical and permanent cure for bedwetting in contrast to the short term relief, if that, offered by expensive and potentially dangerous drugs. The malem bedwetting alarm consists of a safe electronic device contained in a small, ultra lightweight plastic box which is comfortably and discreetly worn on the nightwear top close to the collar bone. The alarm is connected to a sensor which detects urination. When urination commences and the sensor is moistened, the alarm is triggered and a stimulus is activated. This can be in the form of a loud sound, vibration or light. The easy-clip, standard or bed-mat sensors can all be linked to any of the alarms. Repetitive awakening by the alarm as soon as urination commences will gradually train the brain to exert automatic control over the bladder. Eventually, the 'bed-wetter' (child) will either wake up before urination or be cured resulting in them sleeping throughout the night without needing to empty the bladder. This form of treatment has proved to be the safest, most reliable and economical way of curing bedwetting with over 90% success within a few weeks and has no side effects. Findings - mechanical hazards: choking hazards; the malem alarm battery door qualifies (is defined as) a small part which can cause choking hazard in children. This is in conflict (non-conformance) with 16 cfr 1501. 2; the malem has small parts which can come off the product when dropped and swallowed by child. This is in conflict (non-conformance) with en71 / astm f963; the malem clip (on back of alarm) may clamp down on child's finger or if breaks, the sharp metal can cut skin. Lab reply: this can be seen as a potential problem of sharp point. This is in conflict (non-conformance) with astm f963, en71 and/or 16cfr; findings - labeling offensives: no labeling on any malem medical device calls out age appropriate guidance for the intended user. This is in conflict (non-conformance) with en71 and astm f963. For obvious reasons (as called out in section 2. 4 "marketing non-compliances") and because the battery cover falls within the small parts regulation the device should be indicated for which age range this device is intended for. There are many brochures we found that do not call out children (as the first two in this section do). However, this brochure calls out the benefit of the device for "potty training" enhancement. While bedwetting may be justified as a problem for any individual of any age. Potty training is widely defined as a teaching method for toddlers (ages 2 to 3 years of age). (b)(6). Age and claim misrepresentation on malem medical website. For several years, malem alarms sold in the usa has shipped with 'safety pins' to attach the alarm unit to the child's t-shirt. These safety pins were longer than 2 inches in length and were placed less than an inch away from the child's neck when they sleep. These could pose a serious potential hazard for children, the effects of which could be fatal to children. There was one report of a child getting injured with the safety pin on (b)(6) which has since been removed. There are estimated well over (b)(4) malem alarms that still have this safety pin in use across the country which we believe are dangerous. Images of the safety pins are shown below. These pins are found in nearly all malem alarms manufactured by the company. In addition to the above malem alarms, the bedwetting store company sells two other popular alarms which we believe will likely fail many of the standards and tests required for children's products sold in the usa. These products include the following: dry-me alarm, rodger clippo alarm. (b)(4).
Patient Sequence No: 1, Text Type: D, B5