OVULITE NONE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-09 for OVULITE NONE manufactured by Unk.

Event Text Entries

[15034648] Rptr purchased an 'ovulite' ovulation predictor. Rptr has questions about the product that their website ovulite. Com does not answer. Rptr called the customer svc number 1-800-923-9023 -both on the website and package itself- and was told they could not answer their questions, that there was no supervisory person rptr could speak to, referred them to their pharmacist -who only referred them back to ovulite- and after their fourth call to the customer svc ctr was told that they 'do not handle that product'. Rptr has been unable to get mfr info -not listed on box, only a distributor is listed- and have gotten no help at all from the so-called 'customer svc' dept.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1033520
• MDR Report Key: 551965
• Date Received: 2004-09-09
• Date of Report: 2004-09-09
• Date of Event: 2004-09-08
• Date Added to Maude: 2004-10-29
• 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: 3
• 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: OVULITE
• Generic Name: SALIVA OVULATION PREDICTOR DEVICE
• Product Code: LHD
• Date Received: 2004-09-09
• Model Number: NONE
• Catalog Number: NONE
• Lot Number: NONE
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 541493
• Manufacturer: UNK
• Manufacturer Address: UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2004-09-09