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 2017-10-30 for SMARTPILL 50100100 manufactured by Given Imaging Ltd., Yoqneam.
[90762259]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[90762260]
According to the reporter, the customer called in to report the patient was experiencing pain the day after ingesting a smartpill capsule. The patient reported on a scale from 1-10 their pain was at a 8. The pain resided in the upper right abdominal and below the flank area of the lower back. Medtronic medical affairs followed-up with the customer and was told the patient had vomited twice. The patient went to the emergency room and spoke with triage, the patient subsequently went home. The customer followed-up with the patient the next day and was told the patient went back to the emergency room after the initially visit. They had a temperature of 102. On (b)(6) 2017 the patient passed the smartpill capsule at approximately 9:30am. The patient underwent a ct scan which showed a kidney abscess. The customer reported the pain and fever the patient experienced was associated with the kidney abscess. The patient will be referred to a specialist.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2017-05585 |
| MDR Report Key | 6987422 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-30 |
| Date of Report | 2017-10-30 |
| Date Mfgr Received | 2017-10-19 |
| Date Added to Maude | 2017-10-30 |
| 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 | SMARTPILL |
| Generic Name | GASTROINTESTINAL MOTILITY SYSTEM, CAPSULE |
| Product Code | NYV |
| Date Received | 2017-10-30 |
| Model Number | 50100100 |
| Catalog Number | 50100100 |
| Lot Number | UNKNOWN |
| 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; 2. Other | 2017-10-30 |