MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2020-03-17 for UNKNOWN PILLCAM manufactured by Given Imaging Ltd., Yoqneam.
[183924131]
Title a case of small bowel adenocarcinoma that caused intestinal obstruction after administration of patency capsule source clinical journal of gastroenterology, date of publication: 11 dec 2019. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183924132]
According to literature source of study performed, the patient was hospitalized with iron deficiency anemia and exertional chest pain. Assessment of intestinal patency was performed. Thirty-three hours after administration, excretion of tag-less patency capsule was not confirmed. An abdominal contrast-enhanced computed tomography (ct) showed arrest of tag-less patency capsule in the small bowel and thickening of the bowel wall, suggested a small bowel tumor. Four days after the administration of tag-less patency capsule, the patient developed abdominal pain and vomiting. Intestinal obstruction was diagnosed by abdominal radiograph. A diagnosis of small bowel tumor with intestinal obstruction was made and laparotomy with surgical resection was performed. The tumor was histologically an adenocarcinoma. The patient had a good clinical course and was discharged 16 days post-surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2020-00132 |
| MDR Report Key | 9840829 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2019-10-03 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-17 |
| 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 Country | IL |
| 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 | 2020-03-17 |
| 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 IL 20692 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-17 |