MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-04 for BOUFFANT CAPS PRO SERIES NON30233B manufactured by Medline Industries.
[24996159]
Patient Sequence No: 1, Text Type: N, H10
[24996160]
A new box of bouffant caps was opened. Upon opening the intact box, a pair of fingerless gloves were found inside the box.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5055972 |
| MDR Report Key | 5055972 |
| Date Received | 2015-09-04 |
| Date of Report | 2015-08-07 |
| Date of Event | 2015-08-04 |
| Report Date | 2015-08-05 |
| Date Reported to FDA | 2015-08-05 |
| Date Reported to Mfgr | 2015-08-05 |
| Date Added to Maude | 2015-09-04 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Brand Name | BOUFFANT CAPS PRO SERIES |
| Generic Name | CAP, SURGICAL |
| Product Code | FYF |
| Date Received | 2015-09-04 |
| Catalog Number | NON30233B |
| Lot Number | 54214121119 |
| Device Availability | * |
| Device Age | 14 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-04 |