MAUDE Adverse Event Report: GIVEN IMAGING LTD. BRAVO REFLUX CAPSULE AND CALIBRATION FREE REFLUX CAPSULES; ELECTRODE, PH, STOMACH

Model Number FGS-0313

Device Problem Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Voluntary recall of bravo reflux capsule and calibration-free reflux capsules item #s fgs-0312, fgs-0313, fgs-0635, and fgs-0636.Did not have any of the product numbers or affected lot numbers in stock.Fda safety report id# (b)(4).

• Brand Name: BRAVO REFLUX CAPSULE AND CALIBRATION FREE REFLUX CAPSULES
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD.
• MDR Report Key: 13118147
• MDR Text Key: 283154060
• Report Number: MW5106365
• Device Sequence Number: 2
• Product Code: FFT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/27/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: FGS-0313
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1