MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-02-14 for PILLCAM * manufactured by Given Imaging Inc.
[21379576]
A capsule endoscopy failed on a quadriplegic patient. This was due to capsule failure as confirmed by given imaging, the manufacturer of the imaging capsule. Given imaging was asked if it was advisable to discontinue using the capsules of that lot. Given imaging advised the hospital to continue using the rest of the capsules in that lot group.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 575843 |
| MDR Report Key | 575843 |
| Date Received | 2005-02-14 |
| Date of Report | 2005-02-14 |
| Date of Event | 2004-11-24 |
| Report Date | 2005-02-14 |
| Date Reported to FDA | 2005-02-14 |
| Date Added to Maude | 2005-02-28 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PILLCAM |
| Generic Name | ENDOSCOPIC CAPSULE IMAGER |
| Product Code | NSI |
| Date Received | 2005-02-14 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 565691 |
| Manufacturer | GIVEN IMAGING INC |
| Manufacturer Address | OAKBROOK TECHNOLOGY CENTER 5555 OAKBROOK PARKWAY, 355 NORCROSS GA 30093 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-02-14 |