ORTHO *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-07-21 for ORTHO * manufactured by *.

Event Text Entries

[300484] Complainant stated that she used a birth control product that was outdated. The product expired in 9/02. She now believes that she maybe pregnant because her "cycle" is late. She purchased the product in 2003 and used it the same night.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4003544
• MDR Report Key: 476220
• Date Received: 2003-07-21
• Date of Report: 2003-06-06
• Date Added to Maude: 2003-08-08
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ORTHO
• Generic Name: CONCEPTROL GEL
• Product Code: LLR
• Date Received: 2003-07-21
• Model Number: *
• Catalog Number: *
• Lot Number: 20L 429C
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 465046
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2003-07-21