SINGLE USE 6MM PIERCER PROBE - SLIM - 180MM - STERILE OHP2062SU

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-10-31 for SINGLE USE 6MM PIERCER PROBE - SLIM - 180MM - STERILE OHP2062SU manufactured by Orthofix Srl.

MAUDE Entry Details

• Report Number: 9680825-2019-00070
• MDR Report Key: 9260928
• Report Source: DISTRIBUTOR,FOREIGN
• Date Received: 2019-10-31
• Date of Report: 2019-10-31
• Date of Event: 2019-08-24
• Date Mfgr Received: 2019-10-08
• Device Manufacturer Date: 2019-01-24
• Date Added to Maude: 2019-10-31
• 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: MR. ROBERTO DONADELLO
• Manufacturer Street: VIA DELLE NAZIONI, 9
• Manufacturer City: BUSSOLENGO, VERONA, ITALY 37012
• Manufacturer Country: IT
• Manufacturer Postal: 37012
• Manufacturer G1: ORTHOFIX SRL
• Manufacturer Street: VIA DELLE NAZIONI, 9
• Manufacturer City: BUSSOLENGO, VERONA, 37012
• Manufacturer Country: IT
• Manufacturer Postal Code: 37012
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SINGLE USE 6MM PIERCER PROBE - SLIM - 180MM - STERILE
• Generic Name: SINGLE USE 6MM PIERCER PROBE - SLIM - 180MM - STERILE
• Product Code: JDX
• Date Received: 2019-10-31
• Model Number: OHP2062SU
• Catalog Number: OHP2062SU
• Lot Number: B1234097
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ORTHOFIX SRL
• Manufacturer Address: VIA DELLE NAZIONI, 9 BUSSOLENGO, VERONA, 37012 IT 37012

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-10-31