MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-05-31 for NON27712EL manufactured by Medline Industries Inc..
[109639969]
It was reported that the end-user went into anaphylactic shock related to use of the face mask. Per the reporting facility, no definitive issue with the face mask in question was identified. It was unknown what medical intervention was required as a result of the reported anaphylactic shock. Despite good faith efforts to obtain additional information, the reporting facility was unable or unwilling to provide any further patient, product, or procedural details. Due to the reported anaphylactic shock and in an abundance of caution, this medwatch is being filed. The sample is not available to be returned for evaluation. A root cause cannot be determined at this time. No additional information is available. If additional relevant information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[109639970]
It was reported that the end-user went into anaphylactic shock related to use of face mask.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2018-00046 |
| MDR Report Key | 7556622 |
| Report Source | USER FACILITY |
| Date Received | 2018-05-31 |
| Date of Report | 2018-05-31 |
| Date of Event | 2018-05-08 |
| Date Mfgr Received | 2018-05-10 |
| Date Added to Maude | 2018-05-31 |
| 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 | BERMON PUNZALAN |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 2249311514 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | MASK,FACE,MAX FLUID PROTECT,EARLOOP |
| Product Code | FXX |
| Date Received | 2018-05-31 |
| Catalog Number | NON27712EL |
| Lot Number | 13MA04111 |
| Device Availability | N |
| 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 | 2018-05-31 |