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.
[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
| Report Number | 9710107-2020-00007 |
| MDR Report Key | 9543967 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2020-01-03 |
| Date of Report | 2020-01-03 |
| Date of Event | 2019-07-11 |
| Date Mfgr Received | 2019-12-20 |
| Date Added to Maude | 2020-01-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AMY BEEMAN |
| Manufacturer Street | 161 CHESHIRE LANE, SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| Manufacturer Phone | 7632104064 |
| Manufacturer G1 | GIVEN IMAGING LTD., YOQNEAM |
| Manufacturer Street | YETSIRA 13 STREET |
| Manufacturer City | YOQNEAM 20692 |
| Manufacturer Postal Code | 20692 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN PILLCAM |
| Generic Name | SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE |
| Product Code | NEZ |
| Date Received | 2020-01-03 |
| Model Number | UNKNOWN PILLCAM |
| Catalog Number | UNKNOWN PILLCAM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN IMAGING LTD., YOQNEAM |
| Manufacturer Address | YETSIRA 13 STREET YOQNEAM 20692 20692 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-03 |