CIDEX? OPA TEST STRIPS 20392

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 2019-09-13 for CIDEX? OPA TEST STRIPS 20392 manufactured by Advanced Sterilization Products.

MAUDE Entry Details

• Report Number: 2084725-2019-00941
• MDR Report Key: 9035119
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2019-09-13
• Date of Report: 2019-08-30
• Date of Event: 2019-08-21
• Date Mfgr Received: 2019-10-17
• Device Manufacturer Date: 2018-07-01
• 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
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. GABRIELA MCLELLAN
• Manufacturer Street: 33 TECHNOLOGY DRIVE
• Manufacturer City: IRVINE CA 92618
• Manufacturer Country: US
• Manufacturer Postal: 92618
• Manufacturer Phone: 949453-639
• Manufacturer G1: ADVANCED STERILIZATION PRODUCTS
• Manufacturer Street: 33 TECHNOLOGY DRIVE
• Manufacturer City: IRVINE CA 92618
• Manufacturer Country: US
• Manufacturer Postal Code: 92618
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CIDEX? OPA TEST STRIPS
• Generic Name: BIOCIDES TEST STRIPS (JOJ)
• Product Code: JOJ
• Date Received: 2019-09-13
• Catalog Number: 20392
• Lot Number: 032699
• Device Expiration Date: 2019-05-28
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ADVANCED STERILIZATION PRODUCTS
• Manufacturer Address: 33 TECHNOLOGY DRIVE IRVINE CA 92618 US 92618

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-09-13