MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-03 for AERO CHROME BREATHABLE PERFORMANCE GOWN UNKNOWN manufactured by O&m Halyard, Inc..
[178139495]
A sample was requested but not provided; however, the statement provided on twitter was accompanied by a photo of the user experience. A device history record is not available as the device code and the lot code was not provided. All information reasonably known as of 27jan2020 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, inc. 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 halyard health complaint database and identified as complaint (b)(4). Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[178139496]
It was reported via social media that a physician experienced an adverse event. After follow-up by an o&m halyard representative, the physician stated, "one dr. Stated that he had a injury on his hand and was bothered that it was covered in blood after the procedure. " additional information was requested but not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680646-2020-00001 |
| MDR Report Key | 9659066 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-03 |
| Date of Report | 2020-02-17 |
| Date of Event | 2019-01-10 |
| Date Mfgr Received | 2020-02-17 |
| Date Added to Maude | 2020-02-03 |
| 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. KEISHA WEAVER |
| Manufacturer Street | 5405 WINDWARD PARKWAY |
| Manufacturer City | ALPHARETTA GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal | 30004 |
| Manufacturer Phone | 4702804383 |
| Manufacturer G1 | O&M HALYARD HONDURAS SA DE C.V |
| Manufacturer Street | CARRETERA TEGUCIGALPA |
| Manufacturer City | VILLANEVA, CORTES |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AERO CHROME BREATHABLE PERFORMANCE GOWN |
| Generic Name | SURGICAL GOWNS |
| Product Code | FYA |
| Date Received | 2020-02-03 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2020-02-03 |