MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-09 for PILLCAM manufactured by Given Imaging Inc..
[126655928]
Patient swallowed a 12-hour pillcam capsule (mhv-huc-7, lot#41402x) for a capsule endoscopy. Study length after download was 1:54:06 hours which was a very shortened exam and gaps noticed. Study sent to medtronic pillcam tech support to determine why study was shortened. Tech support report shows a "bad sensor belt".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8054871 |
| MDR Report Key | 8054871 |
| Date Received | 2018-11-09 |
| Date of Report | 2018-10-22 |
| Date of Event | 2018-10-19 |
| Report Date | 2018-10-22 |
| Date Reported to FDA | 2018-10-22 |
| Date Reported to Mfgr | 2018-11-09 |
| Date Added to Maude | 2018-11-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PILLCAM |
| Generic Name | SYSTEM, IMAGING, ESOPHAGEAL, WIRELESS, CAPSULE |
| Product Code | NSI |
| Date Received | 2018-11-09 |
| Lot Number | 41402X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN IMAGING INC. |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-09 |