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 2015-12-16 for SMARTPILL CAPSULE, SINGLE 50100100 manufactured by Given Imaging Ltd.
[33699175]
(b)(4). The sample has not been received for evaluation. If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[33699176]
It was reported that the capsule was retrieved by an egd procedure. No further information was obtained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2015-00302 |
| MDR Report Key | 5305159 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-12-16 |
| Date of Report | 2014-10-26 |
| Date Mfgr Received | 2014-10-26 |
| Date Added to Maude | 2015-12-16 |
| 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 CAPSULE, SINGLE |
| Generic Name | GASTROINTESTINAL MOTILITY SYSTEM, CAPSULE |
| Product Code | NYV |
| Date Received | 2015-12-16 |
| Model Number | 50100100 |
| Catalog Number | 50100100 |
| Operator | PHYSICIAN |
| 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 | 1. Required No Informationntervention | 2015-12-16 |