MAUDE Adverse Event Report: TACTILE SYSTEMS TECHNOLOGY INC.DBA TACTILE MEDICAL ENTRE SYSTEM; SLEEVE, LIMB, COMPRESSIBLE

Model Number	PD08-U
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	01/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Return product evaluation performed on 2/1/2019 and product met specification.
Event or Problem Description
Entre controller pd08-u and short full leg garment l-fl-sh-a were ordered on 11/12/2018, shipped on 11/15/18 and delivered on 11/15/2018.Patient delayed using the entre system, controller and garment, until her family was in town to assist her, she then used it a total of three times during the week of (b)(6) 2019.She stated the device was initially set on low pressure and then felt there wasn't enough pressure so she changed the pressure to medium, she stated they never used it on high.After the third use the patient noticed pain and significant increase in swelling in both legs.Prior to using the entre system the patient stated their left leg had swelling for a long time, but right leg was ok.She now state the right and left leg are both significantly swollen and painful.She has not used the entre system since the onset of these symptoms.Patient called the doctor's office the week of (b)(6) 2019 to report symptoms and was seen by the prescriber on (b)(6) 2019.Imaging revealed dvts bilaterally in mid to distal region of superficial femoral veins, above the knees.Pt began anticoagulation therapy after (b)(6) 2019.Patient has been advised to avoid the pneumatic compression therapy.

• Brand Name: ENTRE SYSTEM
• Common Device Name: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): TACTILE SYSTEMS TECHNOLOGY INC.DBA TACTILE MEDICAL; 151 5th ave nw; new brighton MN 55112
• MDR Report Key: 9035483
• Report Number: 3004183730-2019-00001
• Device Sequence Number: 14007907
• Product Code: JOW
• UDI-Device Identifier: 00816305020007
• UDI-Public: 00816305020007
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 01/15/2019

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: PD08-U
• Device Lot Number: 18282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 09/13/2019
• 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: Required Intervention
• Patient Weight: 54