MAUDE Adverse Event Report: TACTILE SYSTEMS TECHNOLOGY INC.DBA TACTILE MEDICAL ENTRE SYSTEM; PNEUMATIC COMPRESSION DEVICE

Model Number	PD08-U
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	01/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
While using the pd08-u system, the patient stated they were diagnosed with nerve damage and chronic compartment syndrome.The patient had many other preexisting conditions and tactile medical was unable to confirm the entre system caused the nerve damage and chronic compartment syndrome but upon review with our chief medical officer in an abundance of caution we are relating her compartment syndrome possibly to being influenced by the pd08-u system.Tactile medical will pick up the entre system, the patient does not want to use it anymore.There were no device defects identified upon return product evaluation.The device performed as intended.
Event or Problem Description
The patient was shipped an entre controller pd08-u (b)(4) and two entre short full leg garments l-fl-sh-a, lot 018014, and an entre y-connector pd08-u, lot 300575 on (b)(6) 2021.The patient started using the entre system the end of (b)(6) 2021.They used the entre system about 2 to 2.5 weeks with no issues, they enjoyed the "massage" and reported they changed the pressure to medium from low a few times.On (b)(6) 2022, the patient noted left knee pain but continued the use the entre system and reported no other issues, so they used the entre system the following day and had pain, so they stopped using the entre system on the left leg only.On (b)(6) 2022, the patient called tactile medical and stated they were seen by their neurologist and diagnosed with nerve damage and chronic compartment syndrome, the patient stated it will take over a year to recover and will continue with current treatment- elevation, ice, prednisone, and pain medication.Neurologist also told the patient they possibly could have had a weak vessel which led to the bleeding (hematoma), and the blood got hard and encapsulated in the compartment and around the nerve causing the pain.Tactile medical reviewed this with our chief medical office on 5/2/2022, and our conclusion is tactile medical is including the entre as a possible etiology of the hematoma in the absence of any other definitive episode and with an abundance of caution.

• Brand Name: ENTRE SYSTEM
• Common Device Name: PNEUMATIC COMPRESSION DEVICE
• Manufacturer (Section D): TACTILE SYSTEMS TECHNOLOGY INC.DBA TACTILE MEDICAL; 151 5th avenue nw; new brighton MN 55112
• Manufacturer (Section G): TACTILE SYSTEMS TECHNOLOGY INC.DBA TACTILE MEDICAL; 151 5th avenue nw; new brighton MN 55112
• Manufacturer Contact: brett demchuk ; 151 5th avenue nw; new brighton, MN 55112 ; 6123555135
• MDR Report Key: 14438307
• Report Number: 3004183730-2022-00001
• Device Sequence Number: 12157547
• Product Code: JOW
• UDI-Device Identifier: 00816305020007
• UDI-Public: (01)00816305020007
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K143185
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/25/2022

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 Catalogue Number: PD08-U
• Device Lot Number: 018014, 300575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 82 KG