23GA HORIZONTAL SCISSORS, MEDIUM CURVE, FINE TIP D23.76.23

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-19 for 23GA HORIZONTAL SCISSORS, MEDIUM CURVE, FINE TIP D23.76.23 manufactured by Bausch + Lomb.

MAUDE Entry Details

• Report Number: 0001932402-2019-00004
• MDR Report Key: 9089027
• Date Received: 2019-09-19
• Date of Report: 2019-08-27
• Date of Event: 2019-07-17
• Report Date: 2005-01-01
• Date Reported to FDA: 2005-01-01
• Date Reported to Mfgr: 2005-01-10
• Date Mfgr Received: 2019-10-14
• Device Manufacturer Date: 2018-04-30
• Date Added to Maude: 2019-09-19
• 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: MS. JULI MOORE
• Manufacturer Street: 3365 TREE COURT INDUSTRIAL BLV
• Manufacturer City: ST. LOUIS MO 63122
• Manufacturer Country: US
• Manufacturer Postal: 63122
• Manufacturer Phone: 6362263220
• Manufacturer G1: SYNERGETICS
• Manufacturer Street: 3845 CORPORATE CENTRE DRIVE
• Manufacturer City: O''FALLON MO 63368
• Manufacturer Country: US
• Manufacturer Postal Code: 63368
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: 23GA HORIZONTAL SCISSORS, MEDIUM CURVE, FINE TIP
• Generic Name: HANDHELD SURGICAL INSTRUMENT
• Product Code: HNF
• Date Received: 2019-09-19
• Returned To Mfg: 2019-09-24
• Model Number: D23.76.23
• Lot Number: M0015209
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BAUSCH + LOMB
• Manufacturer Address: ROCHESTER NY 14609 US 14609

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-09-19