MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-07-15 for PRO SERIES * NON28233B manufactured by Medline.
[2123566]
Surgical technician noted that the surgical caps, "bouffont caps" were a much darker color than usual when the was box opened. The technician noted that the left side of her hairline was red "like a burn. " she was sent to employee health for follow up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2170268 |
| MDR Report Key | 2170268 |
| Date Received | 2011-07-15 |
| Date of Report | 2011-07-15 |
| Date of Event | 2011-07-15 |
| Report Date | 2011-07-15 |
| Date Reported to FDA | 2011-07-15 |
| Date Added to Maude | 2011-07-20 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRO SERIES |
| Generic Name | CAP, SURGICAL |
| Product Code | FYF |
| Date Received | 2011-07-15 |
| Model Number | * |
| Catalog Number | NON28233B |
| Lot Number | 1005121063 |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Manufacturer Address | ONE MEDLINE PL. MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-15 |