MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-10-17 for PILLCAM? COLON 2 CAPSULE FGS-0521 manufactured by Given Imaging Ltd., Yoqneam.
[89479738]
Patient Sequence No: 1, Text Type: N, H10
[89479739]
According to the reporter, the patient ingested the capsule between 8 and 11am, then all oral intake ended at around 11am after the patient ingested 500ml of prep and 500ml of water. The colonoscopy occurred at 4pm, approximately 5 hours later. About 20 minutesinto the colonoscopy, the patient regurgitated the capsule and was breathing spontaneously. Due to this, the patient was admitted for overnight observation and discharged the next day in good condition with no ongoing symptoms. The capsule is expected to be returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2017-05564 |
| MDR Report Key | 6954340 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-10-17 |
| Date of Report | 2017-10-17 |
| Date of Event | 2017-08-16 |
| Date Mfgr Received | 2017-10-09 |
| Date Added to Maude | 2017-10-17 |
| 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 | 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? COLON 2 CAPSULE |
| Product Code | PGD |
| Date Received | 2017-10-17 |
| Model Number | FGS-0521 |
| Catalog Number | FGS-0521 |
| Lot Number | 34035C |
| 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. Hospitalization | 2017-10-17 |