MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM PILLCAM; SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE

Model Number FGS-0353

Device Problem Entrapment of Device (1212)

Patient Problems Abdominal Pain (1685); Fever (1858); Vomiting (2144); Radiation Exposure, Unintended (3164)

Event Date 07/28/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the patient encountered problems after ingesting the capsule, including not passing the capsule for 7 days, and it was then extracted by the patient.Approximately two days after ingestion, there was no change in location of the capsule and it was intact based on an x-ray.Three days after the x-ray, the patient experienced severe abdominal pain, so the physician took another x-ray and observed a slight movement of the capsule, which also appeared to still be intact with no indication that it was dissolving.The patient then reported of still experiencing pain, and that they extracted the capsule.The patient was still experiencing abdominal pain, fever, and had been throwing up.

• Brand Name: PILLCAM
• Type of Device: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer (Section G): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 8925946
• MDR Text Key: 155363094
• Report Number: 9710107-2019-00382
• Device Sequence Number: 1
• Product Code: NEZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/23/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: FGS-0353
• Device Catalogue Number: FGS-0353
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/01/2019
• Initial Date FDA Received: 08/23/2019
• 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): Required Intervention