MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-02-06 for LITE ONE SURGICAL MASK BLUE, 50 28802 991028802 manufactured by O&m Halyard, Inc..
[135217405]
The actual complaint product was not returned for evaluation. A review of the device history record is not possible as no lot number was provided. Root cause could not be determined. All information reasonably known as of 06feb2019 has been included in this health authority report. Should additional information be obtained, a follow-up health authority report will be provided. 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, inc. Complaint database and identified as complaint (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[135217406]
It was reported that following the use of a mask, a doctor had an allergic reaction. The doctor developed swollen lips and tongue and needed treatment, which included steroid injection. The doctor was informed his symptoms were due to an allergic response. Additional information was received on 15-jan-2019 from the doctor that stated, all ok. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616096-2019-00001 |
| MDR Report Key | 8311908 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-02-06 |
| Date of Report | 2019-02-25 |
| Date of Event | 2019-01-10 |
| Date Mfgr Received | 2019-01-10 |
| Date Added to Maude | 2019-02-06 |
| 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 | 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 S. DE R.L. DE C.V. |
| Manufacturer Street | CARRETERA PRESA LA AMISTAD KM 4.5, PARQUE INDUSTRIAL AMIS |
| Manufacturer City | ACUNA, COAHULL 26220 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 26220 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LITE ONE SURGICAL MASK BLUE, 50 |
| Generic Name | ICP FACIAL PROTECTION PRODUCTS |
| Product Code | FXX |
| Date Received | 2019-02-06 |
| Model Number | 28802 |
| Catalog Number | 991028802 |
| Lot Number | UNKNOWN |
| 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 | 2019-02-06 |