MAUDE Adverse Event Report: MUI SCIENTIFIC POLYISOPRENE BALLOON 100ML, OR 600ML; ANORECTAL MOTILITY BALLOON

Catalog Number CBE5P PR CBL7P

Device Problems Burst Container or Vessel (1074); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Distributor reported to mui scientific an anorectal motility balloon might have burst while still inserted into patient's body on (b)(6) 2015.During test, there was a noise that the md believed to be the balloon bursting.The reporting nurse believes it was just a sound caused by the air from the manometric pump.Nursing staff recreated the noise after the study and felt it was from the air going into the bifurcation device and then into the balloon.

• Brand Name: POLYISOPRENE BALLOON 100ML, OR 600ML
• Type of Device: ANORECTAL MOTILITY BALLOON
• Manufacturer (Section D): MUI SCIENTIFIC; mississauga, ontario
• Manufacturer Contact: tammy mui ; 145 traders blvd. east, #34; mississauga, ontario ; CA ; 8905525
• MDR Report Key: 4929754
• MDR Text Key: 22454788
• Report Number: 9611668-2015-00001
• Device Sequence Number: 1
• Product Code: FFX
• Combination Product (y/n): N
• PMA/PMN Number: K823701
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Report Date: 07/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CBE5P PR CBL7P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other