TODAY'S SPONGE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-07-07 for TODAY'S SPONGE manufactured by Mayer Laboratories.

Event Text Entries

[1269289] Today's sponge. I purchased the new today's sponge in 2009. The lot number for the product is 432457. I attempted to remove the sponge after it had been inserted for approximately 8 hours. I was unable to remove the sponge and had to visit an emergency room for removal. The physician assistant who removed it said that the sponge had begun to disintegrate and the string was detached and wrapped around the sponge. I had used the sponge as a backup method years ago and i am aware of how to insert and remove it. I am concerned that the product began to disintegrate during usage. Dose or amount: 1 sponge; frequency: as needed; route: vag. Dates of use: 2009, 8 hours. Diagnosis or reason for use: back up birthcontrol.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5011862
• MDR Report Key: 1413544
• Date Received: 2009-07-07
• Date of Report: 2009-07-07
• Date of Event: 2009-06-09
• Date Added to Maude: 2009-07-21
• 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: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: TODAY'S SPONGE
• Generic Name: SPONGE
• Product Code: LLR
• Date Received: 2009-07-07
• Lot Number: 432457
• Device Expiration Date: 2010-12-31
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MAYER LABORATORIES
• Manufacturer Address: 1950 ADDISON ST. BERKELEY CA 94704 US 94704

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2009-07-07