MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-04-11 for BIOMASK BIOM2001AZ manufactured by Medline Industries, Inc..
[4466066]
While wearing the mask, the end user developed blistering on her face and swelling of her throat.
Patient Sequence No: 1, Text Type: D, B5
[11716298]
The end user is a receptionist in an er and stated that she developed blistering on her face and swelling of her throat while wearing the mask. She was given a steroid injection and prescribed a medrol pack. She had previously been diagnosed with a multiple allergies and was sent for additional testing. Thus far, she has also been diagnosed with a citrus allergy. We have had no other similar incidents reported to us for this device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00038 |
| MDR Report Key | 3761002 |
| Report Source | 06 |
| Date Received | 2014-04-11 |
| Date of Report | 2014-04-04 |
| Date of Event | 2014-02-20 |
| Date Mfgr Received | 2014-03-07 |
| Device Manufacturer Date | 2013-11-01 |
| Date Added to Maude | 2014-04-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JULIE FINLEY |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOMASK |
| Product Code | BSJ |
| Date Received | 2014-04-11 |
| Catalog Number | BIOM2001AZ |
| Lot Number | 13L2910 |
| Operator | LAY USER/PATIENT |
| 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 | MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-04-11 |