MAUDE Adverse Event Report: CHESTER PACKAGING E-Z LUBRICATING JELLY

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Brain Injury (2219)

Event Date 01/17/2013

Event Type  Injury  

Event Description

It was reported that a pt suffered severe allergic reaction to an ingredient in the lubricating jelly during a colonoscopy.

Manufacturer Narrative

A pt with known severe sensitivity to peg underwent a colonoscopy on (b)(6) 2013.The lubricating jelly, which contains peg, was used during the procedure.The pt suffered a severe allergic reaction, causing him to go into cardiac arrest.He was defibrillated, given epinephrine and was admitted to the hospital.He underwent cardiac surgery and was placed on a ventilator.He was reported to have suffered brain damage due to oxygen deprivation.This incident had not been previously reported to us.We have no info to suggest the presence of any prod defect.The root cause has been determined to be an allergic reaction to the lubricating jelly.Due to the reported incident and need for medical/surgical intervention, this medwatch is being filed.

• Brand Name: E-Z LUBRICATING JELLY
• Type of Device: LUBRICATING JELLY
• Manufacturer (Section D): CHESTER PACKAGING; 1900 section rd; cincinnati OH 45237
• Manufacturer Contact: 1900 section rd; cincinnati, OH 45237 ; 5134583540
• MDR Report Key: 4541899
• MDR Text Key: 5541402
• Report Number: 1022110-2015-00001
• Device Sequence Number: 1
• Product Code: KMJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/30/2015
• Initial Date FDA Received: 02/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR