While using the pd32-g3 the patient developed a pulmonary embolism.Per the patients son, the md's have instructed the patient to hold use of the pd32-g3 at this time but they "did not know what the embolism is from".Per tactile medical's chief medical officer the pd32-g3 would not cause or contribute to the development of a dvt however without confirmation from the patients md's that this product caused or contributed to the pulmonary embolism this is being reported as a possible cause.The device performed as intended, there were no device defects reported by the user.
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The patient was shipped a pd32-g3 controller, serial number (b)(4), a half leg regular left garment 3l-hl-rg-l lot 117327 and a half leg regular right garment 3l-hl-rg-r lot 117328 on (b)(6) 2020.On (b)(6) 2020 it was reported by the patient's son that the patient normally has shortness of breath but it has been worse with use of the pd32-g3.Tactile medial advised the patient not use the pd32-g3 until approved by the patients hct.On (b)(6) 2020 tactile medical followed up with the patient and spoke to the patients son who stated the patient was admitted to the hospital on (b)(6) 2020 and treated for a pulmonary embolism and was discharged home on (b)(6) 2020 with oxygen and home nursing / therapy services (note: tactile medical has been communicating with two different family members: one family member reported patient was admitted to hospital on (b)(6) 2020 for blood clots in lungs.Second family member stated this took place on (b)(6) 2020).Per the patients son, the md's have instructed the patient to hold use of the pd32-g3 at this time but they "did not know what the embolism is from".
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