MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-10-18 for RF GROUNDING PAD DISPOSABLE WITH CORD PMA-GP-BAY 109860604 manufactured by Avanos Medical Inc..
[175723680]
The actual complaint product was not returned for evaluation. A review of the device history record is in-progress. All information reasonably known as of (b)(6) 2019 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 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). This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc. Product is defective or caused serious injury. Mw 5089607: the device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[175723681]
An fda medwatch/ fda user facility report # mw 5089607 was received stating, "pt was admitted for radio-ablation procedure post-procedure the pt felt a burning pain on the back of her knee a small blister was noted in the area the injury was most likely due to the grounding pad used during the procedure post-discharge the pt went to (8)(6) and it was determined to be a 2nd degree burn and treated. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011270181-2019-00058 |
| MDR Report Key | 9210221 |
| Report Source | OTHER |
| Date Received | 2019-10-18 |
| Date of Report | 2019-10-18 |
| Date of Event | 2019-08-06 |
| Date Mfgr Received | 2019-09-24 |
| Date Added to Maude | 2019-10-18 |
| 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 | CONMED CORPORATION |
| Manufacturer Street | 525 FRENCH RD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 13502 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RF GROUNDING PAD DISPOSABLE WITH CORD |
| Generic Name | STANDARD RF CABLES & ACCESSORIES |
| Product Code | JOS |
| Date Received | 2019-10-18 |
| Model Number | PMA-GP-BAY |
| Catalog Number | 109860604 |
| Lot Number | 201809255 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2019-10-18 |