MAUDE Adverse Event Report: MEDEGEN MEDICAL PRODUCTS GENT-L-KARE; ENEMA KIT

Model Number 107037

Device Problem Use of Device Problem (1670)

Patient Problem Ulceration (2116)

Event Date 03/20/2019

Event Type  No Answer Provided  

Event Description

Pt came to gi lab for flexible sigmoidoscopy.When procedure started and scope inserted, a cap from an enema was found approx 2 inches into rectum.Pt sustained mucosal ulceration from the cap of an enema.We understand this was user error as enema cap was not removed before enema given.Although, we felt this was a reportable event as the tubing and enema cap are the same color - blue.Fda safety report id# (b)(4).

• Brand Name: GENT-L-KARE
• Type of Device: ENEMA KIT
• Manufacturer (Section D): MEDEGEN MEDICAL PRODUCTS; gallaway TN 38036
• MDR Report Key: 8600384
• MDR Text Key: 144938927
• Report Number: MW5086537
• Device Sequence Number: 1
• Product Code: FCE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 107037
• Device Lot Number: 1060371024
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 70