MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-09-21 for PROCEDURE MASK WITH SO SOFT* EARLOOPS, YELLOW 47117 991047117 manufactured by O&m Halyard, Inc..
[121020744]
The sample is reported to be available, but has not yet been received by the manufacturer. A review of the device history record is not possible as no lot number was provided. All information reasonably known as of 21sep2018 has been included in this health authority report. Should additional information be obtained, a follow-up health authority report will be provided. The information provided by o&m halyard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to o&m halyard, inc. O&m halyard, inc. , has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred. This product incident is documented in the o&m halyard complaint database and identified as complaint (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[121020745]
It was reported by the customer who stated that she experienced an asthma attack on hour into wearing the mask. The customer stated that she experienced shortness of breath, rr 16 bpm, hr 120, saturation of 96%, and welts on her face. She was taken to the emergency room at work and treated with albuterol, then levalbuterol. The customer has had allergy testing and is allergic to albuterol polyester, nuts, latex, grass, and trees. After the levalbuterol treatment the customer's symptoms resolved, the next day the customer also took another inhaler mdi treatment and a nebulizer of levalbuterol. The customer state that she takes benadryl prn or as needed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616096-2018-00002 |
| MDR Report Key | 7897944 |
| Report Source | CONSUMER |
| Date Received | 2018-09-21 |
| Date of Report | 2018-09-27 |
| Date of Event | 2018-08-18 |
| Date Mfgr Received | 2018-09-27 |
| Date Added to Maude | 2018-09-21 |
| 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 | MS. CAROLYN WAITS |
| Manufacturer Street | 5405 WINDWARD PARKWAY |
| Manufacturer City | ALPHARETTA GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal | 30004 |
| Manufacturer Phone | 4704485136 |
| Manufacturer G1 | LA ADA DE ACUNA |
| Manufacturer Street | KM 4.5 CARRETERRA PRESA LA AMI |
| Manufacturer City | CIUDAD DE ACUNA, COAHUILA, CP 26220 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 26220 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROCEDURE MASK WITH SO SOFT* EARLOOPS, YELLOW |
| Generic Name | ICP FACIAL PROTECTION PRODUCTS |
| Product Code | FXX |
| Date Received | 2018-09-21 |
| Model Number | 47117 |
| Catalog Number | 991047117 |
| Lot Number | UNKNOWN |
| 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 | O&M HALYARD, INC. |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-21 |