ACESSA PROVU HANDPIECE 7300

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-06-04 for ACESSA PROVU HANDPIECE 7300 manufactured by Acessa Health Inc..

MAUDE Entry Details

• Report Number: 3006443171-2019-00001
• MDR Report Key: 8666181
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2019-06-04
• Date of Report: 2019-04-29
• Date of Event: 2019-04-29
• Date Mfgr Received: 2019-04-29
• Device Manufacturer Date: 2018-12-07
• Date Added to Maude: 2019-06-04
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. ISAAC RODRIGUEZ
• Manufacturer Street: 7004 BEE CAVE RD. BLDG. 3, STE. 200
• Manufacturer City: AUSTIN TX 78746
• Manufacturer Country: US
• Manufacturer Postal: 78746
• Manufacturer Phone: 5127850707
• Manufacturer G1: ACESSA HEALTH INC.
• Manufacturer Street: 7004 BEE CAVE RD. BLDG. 3, STE. 200
• Manufacturer City: AUSTIN TX 78746
• Manufacturer Country: US
• Manufacturer Postal Code: 78746
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ACESSA PROVU HANDPIECE
• Generic Name: ACESSA
• Product Code: HFG
• Date Received: 2019-06-04
• Returned To Mfg: 2019-04-30
• Model Number: 7300
• Lot Number: 19407418
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ACESSA HEALTH INC.
• Manufacturer Address: 7004 BEE CAVE RD. BLDG. 3, STE. 200 AUSTIN TX 78746 US 78746

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-06-04