MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-11-08 for PILLCAM FGS-0109 manufactured by Given Imaging Ltd., Yoqneam.
[126544660]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[126544661]
According to the reporter, the patency capsule was retained. When the capsule was given the customer returned a month after and complained of abdominal pain. They carried out an x-ray and computed tomography scan (ct-scan) which showed capsule was still in site, they carried out another x-ray and it showed the same thing that the capsule was intact in the site.
Patient Sequence No: 1, Text Type: D, B5
[135335823]
Additional information: evaluation summary: this report is based on information provided by medtronic investigation personnel. The product sample was not returned to the medtronic laboratory; however, an x-ray was provided by the customer for analysis. A review of the product expiration date discovered this product was used before the expiration date. The sample did not meet specification as received by medtronic. The x-ray show retention of patency capsule. The reported condition was confirmed. The investigation identified the root cause of the reported event to be physiological problem. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[135335824]
According to the reporter, the patency capsule was retained. When the capsule was given the customer returned a month after and complained of abdominal pain. They carried out an x-ray and ct scan which showed capsule was still in site, they carried out another x-ray and it showed the same thing that the capsule was intact in the site. The capsule was extracted by the patient after 8 days with no necessary medical intervention.
Patient Sequence No: 1, Text Type: D, B5
[135336383]
Additional information: evaluation summary: it was reported that the patency capsule was retained. The product sample was not returned to the laboratory; however, an x-ray was provided by the customer for analysis. The reported condition was confirmed. The investigation identified the root cause of the reported event to be physiological problem. A review of device history records indicated that the product released meeting all specifications as manufactured. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[135336384]
According to the reporter, the patency capsule was retained. The patient has a history of crohn? S disease and had some abdominal pain before the test. A day after the capsule was given, the patient returned and complained of abdominal pain. The patient was admitted, and an x-ray and ct scan were performed which showed that the patency capsule was still in the small bowel. The patient had another x-ray 5 days post ingestion and the capsule was still seen and intact. The capsule was excreted 8 days after the capsule ingestion without a need for medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2018-01039 |
| MDR Report Key | 8051272 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-11-08 |
| Date of Report | 2019-02-06 |
| Date of Event | 2018-10-10 |
| Date Mfgr Received | 2019-01-13 |
| Date Added to Maude | 2018-11-08 |
| 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 | PILLCAM |
| Generic Name | SYSTEM, IMAGING, ESOPHAGEAL, WIRELESS, CAPSULE |
| Product Code | NSI |
| Date Received | 2018-11-08 |
| Model Number | FGS-0109 |
| Catalog Number | FGS-0109 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Required No Informationntervention | 2018-11-08 |