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 2016-07-06 for SMARTPILL RECORDER, RFB 50100550 manufactured by Given Imaging Ltd.
[48884249]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[48884250]
Customer reports that their patient began a (b)(6) study on (b)(6) 2016 at approx. 08:45am. During the course of the day, the patient reported the ph levels were inconsistent. The patient reported only 1 bm around 11:30am. The patient reported (b)(6) 2016 that there was no activity on the black box receiver. Patient also reported experiencing upper gastric pain and extreme nausea, but no vomiting. Customer confirmed that the patient did have a kub and the capsule did pass within 3 hours of ingesting it.. Physician reports the patient is doing fine, and is expected in their office for a follow up soon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2016-00297 |
| MDR Report Key | 5772949 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-07-06 |
| Date of Report | 2016-06-08 |
| Date Mfgr Received | 2016-06-08 |
| Device Manufacturer Date | 2016-03-07 |
| Date Added to Maude | 2016-07-06 |
| 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 | 540 OAKMEAD PARKWAY |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal | 94085 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | GIVEN IMAGING LTD |
| Manufacturer Street | 2 HACARMEL ST. P.O. BOX 258 |
| Manufacturer City | NEW INDUSTRIAL PARK, YOQNEAM 20692 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 20692 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTPILL RECORDER, RFB |
| Generic Name | SMARTPILL |
| Product Code | NYV |
| Date Received | 2016-07-06 |
| Model Number | 50100550 |
| Catalog Number | 50100550 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN IMAGING LTD |
| Manufacturer Address | 2 HACARMEL ST. P.O. BOX 258 NEW INDUSTRIAL PARK, YOQNEAM 20692 IS 20692 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-06 |