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

Model Number	FGS-0668
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	03/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, the patency capsule took longer than normal to dissolve out the patient's body.It passes out the patient's body between (b)(6) 2022 or (b)(6) 2022 per x-ray results.The customer stated that the patient was hospitalized on (b)(6) 2022 for abdominal pain and discharged on (b)(6) 2022.The abdominal pain resolved after the patency capsule passed out of the patient's body.

• Brand Name: PILLCAM
• Common Device Name: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, C
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IS 20692
• Manufacturer (Section G): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IS 20692
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 14214792
• Report Number: 9710107-2022-00097
• Device Sequence Number: 19283469
• Product Code: NEZ
• UDI-Device Identifier: 07290110360825
• UDI-Public: 07290110360825
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K090557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/26/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/24/2022
• Device Model Number: FGS-0668
• Device Catalogue Number: FGS-0668
• Device Lot Number: 53806
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 04/26/2022
• Date Device Manufactured: 06/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Race: White