UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-05 for UNKNOWN manufactured by Rotation Medical, Inc..

Event Text Entries

[165207631] It was reported that after a case in which a regeneten patch was used, the patient had a reaction. The patient has been treated with antibiotics. Patient outcome is unknown. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3009351468-2019-00116
• MDR Report Key: 9282274
• Date Received: 2019-11-05
• Date of Report: 2019-11-05
• Date Mfgr Received: 2019-10-11
• Date Added to Maude: 2019-11-05
• 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: HOLLY TOPPING
• Manufacturer Street: 7000 WEST WILLIAM CANNON DRIVE
• Manufacturer City: AUSTIN TX 78735
• Manufacturer Country: US
• Manufacturer Postal: 78735
• Manufacturer Phone: 5123913905
• Manufacturer G1: ROTATION MEDICAL, INC.
• Manufacturer Street: 15350 25TH AVE. NO., SUITE 100
• Manufacturer City: PLYMOUTH MN
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: UNKNOWN
• Generic Name: MESH, SURGICAL, DEPLOYER
• Product Code: ORQ
• Date Received: 2019-11-05
• Catalog Number: UNKNOWN
• Lot Number: UNKNOWN
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ROTATION MEDICAL, INC.
• Manufacturer Address: 15350 25TH AVE. NO., SUITE 100 PLYMOUTH MN

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-11-05