MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-06-01 for SMARTPILL 50100100 manufactured by Given Imaging Ltd., Yoqneam.
[76433067]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[76433068]
According to the reporter, patient had a retained smartpill capsule, less than 14 days. Patient called in complaint that the capsule had not passed several days after ingested. Patient had x-ray 5 days after ingesting capsule and x-ray showed the capsule was present. Patient had another x-ray 12 days after ingestion that showed capsule had passed as capsule was not present. There was no follow up attention required since capsule had passed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2017-05255 |
| MDR Report Key | 6605079 |
| Report Source | CONSUMER |
| Date Received | 2017-06-01 |
| Date of Report | 2017-05-15 |
| Date of Event | 2016-10-24 |
| Date Mfgr Received | 2017-05-15 |
| Date Added to Maude | 2017-06-01 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | 2034925267 |
| 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 | SMARTPILL |
| Generic Name | GASTROINTESTINAL MOTILITY SYSTEM, CAPSULE |
| Product Code | NYV |
| Date Received | 2017-06-01 |
| Model Number | 50100100 |
| Catalog Number | 50100100 |
| 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. Required No Informationntervention | 2017-06-01 |