MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-15 for NON28625 manufactured by Medline.
[36655442]
Dead insect found in fold of non sterile surgeon cap.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5059482 |
| MDR Report Key | 5383827 |
| Date Received | 2016-01-15 |
| Date of Report | 2016-01-15 |
| Date of Event | 2016-01-13 |
| Date Added to Maude | 2016-01-21 |
| 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 |
| Generic Name | NON STERILE SURGEON CAP |
| Product Code | FYF |
| Date Received | 2016-01-15 |
| Catalog Number | NON28625 |
| Lot Number | 85815071397 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-15 |