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 2017-10-23 for PILLCAM? PATENCY CAPSULE FGS-0109 manufactured by Given Imaging Ltd., Yoqneam.
[89945708]
Patient Sequence No: 1, Text Type: N, H10
[89945709]
According to the reporter, the device had retained patency capsule. The rfid tag had been retained in the patient for about 2 weeks. Customer was requesting to be contacted by the medical advisors. No patient harm reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2017-05576 |
| MDR Report Key | 6968421 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-23 |
| Date of Report | 2017-10-23 |
| Date of Event | 2017-08-18 |
| Date Mfgr Received | 2017-10-12 |
| Date Added to Maude | 2017-10-23 |
| 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 | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 2034925297 |
| 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? PATENCY CAPSULE |
| Generic Name | SYSTEM, IMAGING, ESOPHAGEAL, WIRELESS, CAPSULE |
| Product Code | NSI |
| Date Received | 2017-10-23 |
| Model Number | FGS-0109 |
| Catalog Number | FGS-0109 |
| Lot Number | 35938 |
| 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 20692 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-23 |