MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-10 for PAIN MANAGEMENT GENERATOR, VERSION 4.1.1, ADVANCED PMG-115-TD 109865408 manufactured by Avanos Medical Inc..
[185495579]
The sample is reported to be available but has not yet been received by the manufacturer. A review of the device history record is in-progress. All information reasonably known as of 10-mar-2020 included in this health authority report. Should additional information be obtained, a follow-up health authority report will be provided. The information provided by avanos medical, inc. Represents all of the known information at this time. Avanos medical, 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 avanos medical, inc. Complaint database and identified as complaint (b)(4). The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[185495580]
It was reported the unit started smoking when the clinicians turned it on, so they quickly unplugged. There was no reported injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011270181-2020-00043 |
| MDR Report Key | 9813348 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-11 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2012-10-03 |
| Date Added to Maude | 2020-03-10 |
| 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. LISA CLARK |
| Manufacturer Street | 5405 WINDWARD PARKWAY |
| Manufacturer City | ALPHARETTA GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal | 30004 |
| Manufacturer Phone | 4704485444 |
| Manufacturer G1 | STELLARTECH RESEARCH CORP. |
| Manufacturer Street | 560 COTTONWOOD DR |
| Manufacturer City | MILPITAS CA 95035 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95035 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PAIN MANAGEMENT GENERATOR, VERSION 4.1.1, ADVANCED |
| Generic Name | PAIN MANAGEMENT GENERATORS & ACCESSORIES |
| Product Code | GXD |
| Date Received | 2020-03-10 |
| Model Number | PMG-115-TD |
| Catalog Number | 109865408 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AVANOS MEDICAL INC. |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-10 |