MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-15 for FIRST STEP ENDOSCOPE PRECLEAN KIT EP-6W manufactured by Cygnus Medical.
[40784106]
An opened chocolate candy bar wrapper with broken pieces of chocolate candy inside we found inside a sealed sterile container.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5060947 |
| MDR Report Key | 5510738 |
| Date Received | 2016-03-15 |
| Date of Report | 2016-03-15 |
| Date of Event | 2016-03-11 |
| Date Added to Maude | 2016-03-18 |
| 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 |
| 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 | 0 |
| Brand Name | FIRST STEP ENDOSCOPE PRECLEAN KIT |
| Generic Name | ENDOSCOPE PRECLEAN KIT |
| Product Code | LRP |
| Date Received | 2016-03-15 |
| Model Number | EP-6W |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CYGNUS MEDICAL |
| Manufacturer Address | BRANFORD CT 06405 US 06405 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-15 |