MAUDE Adverse Event Report: TACTILE SYSTEMS TECHNOLOGY INC.DBA TACTILE MEDICAL FLEXITOUCH PLUS SYSTEM; PNEUMATIC COMPRESSION DEVIC

Model Number	PD32-G3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	12/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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".

• Brand Name: FLEXITOUCH PLUS SYSTEM
• Common Device Name: PNEUMATIC COMPRESSION DEVIC
• Manufacturer (Section D): TACTILE SYSTEMS TECHNOLOGY INC.DBA TACTILE MEDICAL; 151 5th avenue nw; new brighton MN 55112
• MDR Report Key: 11174946
• Report Number: 3004183730-2021-00002
• Device Sequence Number: 16711969
• Product Code: JOW
• UDI-Device Identifier: 00816305023381
• UDI-Public: (01)00816305023381
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K170216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: PD32-G3
• Device Catalogue Number: PD32-G3
• Device Lot Number: 117327, 117328
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 01/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 80