MAUDE Adverse Event Report: MEDSPIRA LLC MCOMPASS MANOMETRIC BIOFEEDBACK SYSTEM; DEVICE, BIOFEEDBACK

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/04/2019

Event Type  malfunction  

Event Description

Medspira biofeedback device was inserted into rectum to measure sensitivity and pressure.Balloon on the end of catheter was gradually inflated during procedure and eventually popped inside of me.Due to my hyposensitivity, no pain was felt when this happened or afterwards and procedure was terminated.Fda safety report id# (b)(4).

• Brand Name: MCOMPASS MANOMETRIC BIOFEEDBACK SYSTEM
• Type of Device: DEVICE, BIOFEEDBACK
• Manufacturer (Section D): MEDSPIRA LLC
• MDR Report Key: 8683962
• MDR Text Key: 147728231
• Report Number: MW5087234
• Device Sequence Number: 1
• Product Code: HCC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 68