MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-02-01 for NONSH700WXL manufactured by Medline Industries Inc..
[98838098]
It was reported that a staff member experienced a reaction after putting on a surgeon's hood. It was reported that after five minutes of use the staff member experienced redness, bumps, and swelling to the face, neck, and forehead. It was reported that the staff member took benadryl and following an unknown period of time, self-administered an epi-pen. It was reported that the staff member carries an epi-pen due to a history of allergies. It was reported that the staff member did not follow up with a hospital or doctor's office after the reported incident. It was reported that after taking the stated medications the reported reaction was resolved. It was reported that the original sample was discarded and is not available to be returned for evaluation. No additional information is available. Due to the reported incident and in an abundance of caution, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[98838099]
It was reported that a staff member experienced a reaction after putting on a surgeon's hood.
Patient Sequence No: 1, Text Type: D, B5
[114594085]
The original sample was reportedly discarded and was not available to be returned to the manufacturer for evaluation. The sample's lot number was provided to the manufacturer. A sample from the lot number was evaluated. Cytoxicity testing was performed and the reported product issue could not be confirmed. Should additional relevant information becomes available, a supplemental medwatch will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2018-00007 |
| MDR Report Key | 7235125 |
| Report Source | USER FACILITY |
| Date Received | 2018-02-01 |
| Date of Report | 2018-03-23 |
| Date of Event | 2018-01-22 |
| Date Mfgr Received | 2018-01-22 |
| Date Added to Maude | 2018-02-01 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NIGEL VILCHES |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 2249311458 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | HOOD, SPP, WHITE, XL |
| Product Code | FYF |
| Date Received | 2018-02-01 |
| Catalog Number | NONSH700WXL |
| Lot Number | 30517110003 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-02-01 |