MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-24 for LAPROSCOPIC CATHETER manufactured by American Catheter.
[5681142]
Packaging for device found not sealed at manufacturer. Found 11 more with same defect in store room. Diagnosis or reason for use: cholangiogram.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5041729 |
| MDR Report Key | 4645468 |
| Date Received | 2015-03-24 |
| Date of Report | 2015-03-24 |
| Date of Event | 2015-03-09 |
| Date Added to Maude | 2015-04-01 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | LAPROSCOPIC CATHETER |
| Product Code | NWT |
| Date Received | 2015-03-24 |
| Lot Number | 14101601 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN CATHETER |
| Manufacturer Address | STUART FL 34997 US 34997 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-24 |