MAUDE Adverse Event Report: NORMATEC INDUSTRIES, LP NORMATEC PUMP; MASSAGER, POWERED INFLATABLE TUBE

Model Number E0651

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Neuropathy (1983); Pain (1994)

Event Date 01/15/2020

Event Type  Injury  

Event Description

Background: bilateral lymphedema after two total hips in 2017; did well until flight from europe in (b)(6) when lymphedema returned.Routine massage therapy didn't work and pressure pump recommended and purchased in late fall 2019.Pump started in (b)(6) bid for 55 minutes twice a day at level 1.Pitting edema in feet and lower legs began in mid (b)(6) 2020 immediately after using pump.Manufacturer rep indicated that swelling in feet was a known occurrence but not in calves.I kept using pump until lymphedema doctor recommended stopping in early (b)(6); i stopped.Incidental note: neuropathy of both legs also developed in (b)(6) 2020 and got worse in (b)(6) with considerable tingling, pain and swelling after using pump (r>l).Pain in middle of night in both feet.Physician felt that neuropathy was not due to pump but could not comment on swelling of feet and calves.Fda safety report id #: (b)(4).

• Brand Name: NORMATEC PUMP
• Type of Device: MASSAGER, POWERED INFLATABLE TUBE
• Manufacturer (Section D): NORMATEC INDUSTRIES, LP
• MDR Report Key: 10326389
• MDR Text Key: 200685186
• Report Number: MW5095732
• Device Sequence Number: 2
• Product Code: IRP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/23/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: E0651
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 84