ENTRE SYSTEM PD08-U

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-09-13 for ENTRE SYSTEM PD08-U manufactured by Tactile Systems Technology Inc.dba Tactile Medical.

MAUDE Entry Details

• Report Number: 3004183730-2019-00001
• MDR Report Key: 9035483
• Report Source: COMPANY REPRESENTATIVE
• Date Received: 2019-09-13
• Date of Report: 2019-01-15
• Date of Event: 2019-01-11
• Date Mfgr Received: 2019-01-15
• Device Manufacturer Date: 2018-10-31
• Date Added to Maude: 2019-09-13
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: BRETT DEMCHUK
• Manufacturer Street: 151 5TH AVE NW
• Manufacturer City: NEW BRIGHTON MN 55112
• Manufacturer Country: US
• Manufacturer Postal: 55112
• Manufacturer Phone: 6123555135
• Manufacturer G1: TACTILE SYSTEMS TECHNOLOGY INC DBA TACTILE MEDICAL
• Manufacturer Street: 151 5TH AVE NW
• Manufacturer City: NEW BRIGHTON MN 55112
• Manufacturer Country: US
• Manufacturer Postal Code: 55112
• Single Use: 3
• Remedial Action: PM
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ENTRE SYSTEM
• Generic Name: SLEEVE, LIMB, COMPRESSIBLE
• Product Code: JOW
• Date Received: 2019-09-13
• Returned To Mfg: 2019-02-01
• Model Number: PD08-U
• Lot Number: 18282
• Operator: LAY USER/PATIENT
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: TACTILE SYSTEMS TECHNOLOGY INC.DBA TACTILE MEDICAL
• Manufacturer Address: 151 5TH AVE NW NEW BRIGHTON MN 55112 US 55112

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-09-13