TRIAD RADIATION STERILIZED STERILE LUBRICATING JELLY * 108500

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-08-18 for TRIAD RADIATION STERILIZED STERILE LUBRICATING JELLY * 108500 manufactured by *.

Event Text Entries

[20349666] Post operatively in recovery room after general anesthesia for cystoscopy and turp upon emerging from qa, he complained of numbness in mouth, face and tongue. Anesthesiologist was called and ask questions regarding technique, supplies used and procedure by crna and surgeon, pacu nurse questioned anesthesiologist "what do you all use to intubate the pt because at another facility i remember that there were other pts with the same reaction c/o the same problem and that the physician investigated and found that the jel used contained methyl paraben. The sterile lubricating jelly used here is triad radiation sterilized lubricating jelly; and lot # 5a27 was used. One of the ingredients contained in the triad jel is methyl paraben. Pharm dir: the investigation and literature research completed as follow: common side effects based on lit search are, 1. Severe contact dermatitis (redness), 2. Swelling, 3. Itching, 4. Pain of the skin, 5. Eye irritation. Pt presented with sensitivity to all of the above side effects. Pt treated with benadryl with effectiveness. Symptoms did not abate until treated. Investigation of incident with the or staff; staff states that they recall that there was a previous similar incident that they think occurred around/about the time we began to use the triad product, but did not recognize or associate the reaction to the triad product at that time. There was no adr report submitted or an adr suspiction. Anesthesiiologist, reviewed the intubation process and the procedure. All airway equipment was verified and latex free, however, the triad jel is inserted on the portion of the lma that is inserted into the pts' buccal cavity to provide a sealed airway, therefore, there is local contact of the jel with the mucous membranes. Pt was severely affected and c/o severe nasal congestion, painful skin around the lips, nose, mouth and chin, swelling of the entire face with puffy eyes, severe, redness around the chin area; numbness on tongue area, lips and chin.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1036526
• MDR Report Key: 746678
• Date Received: 2005-08-19
• Date of Report: 2005-08-18
• Date of Event: 2005-08-16
• Date Added to Maude: 2006-08-14
• 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: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: TRIAD RADIATION STERILIZED STERILE LUBRICATING JELLY
• Generic Name: *
• Product Code: KMJ
• Date Received: 2005-08-18
• Model Number: *
• Catalog Number: 108500
• Lot Number: 5A27
• ID Number: 108500
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 734477
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2005-08-19