MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-11-17 for PILLCAM PATENCY CAPSULE, 5-PACK FGS-0110 manufactured by Given Ltd (israel).
[60098219]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[60098220]
According to the reporter, the patency capsule has not dissolved. The capsule was ingested on (b)(6) 2016. On (b)(6), abdominal xrays showed the capsule in the ascending colon. On (b)(6), another xray showed that the capsule is still in the ascending colon. The patient has experienced frequent diarrhea and her usual nausea and abdominal pain. There is no evidence of obstruction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2016-01096 |
| MDR Report Key | 6109004 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-11-17 |
| Date of Report | 2016-10-28 |
| Date of Event | 2016-10-18 |
| Date Mfgr Received | 2016-10-28 |
| Date Added to Maude | 2016-11-17 |
| 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 | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVENUE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | GIVEN LTD (ISRAEL) |
| Manufacturer Street | 2 HACARMEL ST. NEW INDUSTRIAL POB 258, |
| Manufacturer City | YOQNEAM |
| Manufacturer Country | IS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PILLCAM PATENCY CAPSULE, 5-PACK |
| Generic Name | SYSTEM, IMAGING, ESOPHAGEAL, WIRELESS, CAPSULE |
| Product Code | NSI |
| Date Received | 2016-11-17 |
| Model Number | FGS-0110 |
| Catalog Number | FGS-0110 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN LTD (ISRAEL) |
| Manufacturer Address | 2 HACARMEL ST. NEW INDUSTRIAL POB 258, YOQNEAM IS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-11-17 |