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

Model Number	PD32-U
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A flexitouch controller, pd32-u and right upper extremity (rue) garment, u-as-s2-r, a-tr-00-a were ordered on 8/24/2-17 and shipped on 9/5/2017.Training was completed on 9/8/2017.Training was completed on (b)(6)2017.On (b)(6) 2019 the patient called to report they would like to know how to use her flexitouch device on her arm only.The patient used the flexitouch to manage their right upper quadrant lymphedema, which included chest treatment on the original order.The patient was shipped and trained on the device in november of 2017 and reported pain starting in (b)(6) 2017.In (b)(6) 2018, the patient was seen for follow-up and a ct scan and at that point the patient reported they were diagnosed with stage 4 metastic breast cancer and had 7 acute/chronic rib fractures.The patient did not require hospitalization or treatment for the fractured ribs, the diagnosis was not made until several months after they used the flexitouch and the resulting pain.The fractured ribs were healed at the time of the ct scan.The stage 4 metastic breast cancer as well as the 7 acute/fractured ribs were diagnosed with a ct scan in (b)(6) of 2018; the pt disclosed this information to tactile medical in (b)(6) of 2019 when calling in to ask if it was possible to treat her arm only, with the flexitouch.The patients medical team wants to continue to use the flexitouch product on the patients arm only.
Event or Problem Description
A flexitouch controller, pd32-u and right upper extremity (rue) garment, u-as-s2-r, a-tr-00-a were ordered on (b)(6) 2017 and shipped on (b)(6) 2017.Training was completed on (b)(6) 2017.Training was completed on (b)(6) 2017.On (b)(6) 2019 the patient called to report they would like to know how to use her flexitouch device on her arm only.The patient used the flexitouch to manage their right upper quadrant lymphedema, which included chest treatment on the original order.The patient was shipped and trained on the device in november 2017 and reported pain starting in (b)(6) 2017.In (b)(6) 2018, the patient was seen for follow-up and a ct scan and at that point the patient reported they were diagnosed with stage 4 metastatic breast cancer and had 7 acute/chronic rib fractures.The patient did not require hospitalization or treatment for the fractured ribs, the diagnosis was not made until several months after they used the flexitouch and the resulting pain.The fractured ribs were healed at the time of the ct scan.The stage 4 metastatic breast cancer as well as the 7 acute/fractured ribs were diagnosed with a ct scan in (b)(6) of 2018; the pt disclosed this information to tactile medical in september of 2019 when calling in to ask if it was possible to treat her arm only, with the flexitouch.

• Brand Name: FLEXITOUCH 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
• MDR Report Key: 9099849
• Report Number: 3004183730-2019-00002
• Device Sequence Number: 2664564
• Product Code: JOW
• UDI-Device Identifier: 00816305020106
• UDI-Public: (01)00816305020106
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K153311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Modification/Adjustment,Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 08/20/2019

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: PD32-U
• Device Catalogue Number: PD32-U
• Device Lot Number: 11145, 17023, 113340
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 09/20/2019
• 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: Other
• Patient Age: 61 YR
• Patient Weight: 66