Investigation summary: the root cause category is non-assignable (complaint not confirmed).The sample is not available from consumer for evaluation by the site, the complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.
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Event verbatim [preferred term] pc: nothing inside either box except for what looks like coffee grounds [device leakage] ,.Case narrative:this is a spontaneous report from a contactable consumer.This (b)(6) female consumer started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) from unknown date for arthritis and pain in her legs.Medical history included arthritis, macular degeneration.Concomitant medication was not reported.Consumer purchased two different boxes of thermacare heatwraps, each box was supposed to contain 6 wraps.There was nothing inside either box except for what looked like coffee grounds, no wraps or anything except coffee grounds.She took a picture of the boxes.She had pain in her legs.She had this before ever using the product.She had arthritis and used the product for this.She also had macular degeneration.She confirmed she was diagnosed with arthritis and macular degeneration before using the product.She could not read the details of the box to provide lot, upc, expiration date, or udi since she had macular degeneration.Device was available for evaluation.According to product quality complaint group: investigation summary: the root cause category is non-assignable (complaint not confirmed).The sample is not available from consumer for evaluation by the site, the complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Follow-up (26feb2019): new information received from a product quality complaint group included: investigation results.Follow-up (17dec2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment the event "nothing inside either box except for what looked like coffee grounds" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device., comment: the event "nothing inside either box except for what looked like coffee grounds" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.
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