STERILE JUNIOR TONGUE DEPRESSOR NO. 4313

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-04-03 for STERILE JUNIOR TONGUE DEPRESSOR NO. 4313 manufactured by Dynarex.

Event Text Entries

[14870481] I have observed for a few weeks that our wooden tongue depressors seem to have frequent quality defects that may lead to adverse treatment outcomes. The product is an individual single use package labeled "sterile junior tongue depressor 5 1/2 inch size, reorder". Lot numbers vary. In a sample of 60 tongue depressors on my exam table today, 3 packages felt abnormally thin and flexible. When opened lot 19125 was intact but too thin and flexible to be useful in examination. Lot 19487 was thin and had a 1 cm crack on one end and a small splinter on the other end. Lot 19820 had a crack running along the entire length of the tongue depressor. On other days, i have opened packages with gross chips or discoloration which could not have passed effective quality screening by a competent manufacturer. These defects are not always obvious before use. There is a real danger that a wood spinter may be swallowed or aspirated. We have used this brand here for years and i never encountered a problem like this before.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5010639
• MDR Report Key: 1356528
• Date Received: 2009-04-03
• Date of Report: 2009-04-03
• Date of Event: 2009-04-03
• Date Added to Maude: 2009-04-24
• 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
• 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: STERILE JUNIOR TONGUE DEPRESSOR
• Generic Name: 5 1/2 INCH WOODEN TONGUE DEPRESSOR
• Product Code: FMA
• Date Received: 2009-04-03
• Model Number: NO. 4313
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DYNAREX

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2009-04-03