UNKNOWN PILLCAM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2020-01-03 for UNKNOWN PILLCAM manufactured by Given Imaging Ltd., Yoqneam.

Event Text Entries

[177236932] Title esophageal capsule endoscopy in children and young adults with portal hypertension source original article: hepatology. 641? 647 jpgn volume 69, number 6, december 2019. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[177236933] According to the literature source study performed in july 2019, out of 98 patients, there were two instances of transient esophageal capsule retention, one patient with extrahepatic portal venous obstruction (ehpvo) and a schatzki ring and another patient with fontan associated liver disease (fald) who had undergone multiple cardiac operations. In both cases, the final image captured was of the distal esophagus, and subsequent radiographic studies confirmed esophageal passage without further intervention. There were no reported cases of vomiting, abdominal pain, bowel obstruction, or aspiration.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9710107-2020-00007
MDR Report Key9543967
Report SourceHEALTH PROFESSIONAL,LITERATUR
Date Received2020-01-03
Date of Report2020-01-03
Date of Event2019-07-11
Date Mfgr Received2019-12-20
Date Added to Maude2020-01-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactAMY BEEMAN
Manufacturer Street161 CHESHIRE LANE, SUITE 100
Manufacturer CityPLYMOUTH MN 55441
Manufacturer CountryUS
Manufacturer Postal55441
Manufacturer Phone7632104064
Manufacturer G1GIVEN IMAGING LTD., YOQNEAM
Manufacturer StreetYETSIRA 13 STREET
Manufacturer CityYOQNEAM 20692
Manufacturer Postal Code20692
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN PILLCAM
Generic NameSYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
Product CodeNEZ
Date Received2020-01-03
Model NumberUNKNOWN PILLCAM
Catalog NumberUNKNOWN PILLCAM
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerGIVEN IMAGING LTD., YOQNEAM
Manufacturer AddressYETSIRA 13 STREET YOQNEAM 20692 20692


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-03

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