MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-20 for CAVIWIPES1 13-5100 manufactured by Metrex Research.
[90032797]
Employee was opening a new container of caviwipes 1, when she broke the seal there was a foreign object. It appears to be metal with rust around it. Package was completely sealed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072847 |
| MDR Report Key | 6964347 |
| Date Received | 2017-10-20 |
| Date of Report | 2017-10-17 |
| Date of Event | 2017-10-16 |
| Date Added to Maude | 2017-10-20 |
| 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 | UNKNOWN |
| 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 | CAVIWIPES1 |
| Generic Name | GERMICIDAL WIPES |
| Product Code | LRJ |
| Date Received | 2017-10-20 |
| Model Number | 13-5100 |
| Lot Number | 17-1003PA |
| Device Expiration Date | 2019-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | METREX RESEARCH |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-20 |