MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-29 for CRI1004Z manufactured by Medline Industries, Inc..
[41417071]
It was reported that three students developed eye irritation and skin irritation on their forehead after wearing this cap. One student was treated with an antibiotic ointment. The other two students were treated with an otc eye drop. The etiology of the eye irritation is unknown. Unused samples from the same lot were returned and sent to an independent lab. The test results revealed that the samples were non-cytotoxic. A root cause has not been determined. It is unknown if the bouffant cap caused or contributed to the reported skin and eye irritation. However, due to the need for medical intervention and in an abundance of caution, this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
[41417072]
It was reported that three students developed eye irritation and skin irritation on their forehead after wearing this cap.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2016-00025 |
| MDR Report Key | 5532195 |
| Date Received | 2016-03-29 |
| Date of Report | 2016-03-29 |
| Date Mfgr Received | 2016-03-01 |
| Device Manufacturer Date | 2015-06-01 |
| Date Added to Maude | 2016-03-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 |
| Manufacturer Contact | DIANE CHRISTENSEN |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434747 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | BOUFFANT CAP |
| Product Code | FYF |
| Date Received | 2016-03-29 |
| Catalog Number | CRI1004Z |
| Lot Number | 26315060024 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-03-29 |