MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-26 for DRACO HY0305Z manufactured by Cygnus Medical, Llc.
[143241498]
Deep cleaning pads were found with mold inside sealed package. Expiration date: 12/31/2020. Box was thrown away so we are unsure of the lot number.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8554494 |
| MDR Report Key | 8554494 |
| Date Received | 2019-04-26 |
| Date of Report | 2019-04-17 |
| Date of Event | 2019-04-16 |
| Report Date | 2019-04-17 |
| Date Reported to FDA | 2019-04-17 |
| Date Reported to Mfgr | 2019-04-26 |
| Date Added to Maude | 2019-04-26 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | DRACO |
| Generic Name | ACCESSORIES, CLEANING, PAD |
| Product Code | FRL |
| Date Received | 2019-04-26 |
| Model Number | HY0305Z |
| Catalog Number | HY0305Z |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CYGNUS MEDICAL, LLC |
| Manufacturer Address | 965 W MAIN ST BRANFORD CT 06405 US 06405 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-26 |