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 2019-02-15 for RF GROUNDING PAD DISPOSABLE WITH CORD PMA-GP-BAY 109860601 manufactured by Avanos Medical Inc..
[136349114]
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. All information reasonably known as of 15-feb-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. 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 avanos medical, inc. 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 comp (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[136349115]
It was reported the patient sustained a skin burn under the grounding pad area of the skin. The patient was diabetic. The patient had a left three level lumbar standard radio frequency ablation (sra) on (b)(6) 2019. The grounding pad was placed on the back of the upper left thigh. The patient was not hairy and the grounding pad adhesion appeared normal. The procedure proceeded without incident with both motor and sensory testing, no high impedances nor warnings on pain management generator (pmg). Six days after the procedure the patient went to the emergency room (er) with report of a burn at grounding pad site. The nurse reviewed the skin and described the skin as a full thickness circular wound the size of a dime. It is unknown what treatment was done in the er. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011270181-2019-00006 |
| MDR Report Key | 8345777 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-02-15 |
| Date of Report | 2019-01-30 |
| Date of Event | 2019-01-24 |
| Date Mfgr Received | 2019-01-30 |
| Date Added to Maude | 2019-02-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 6455 S YOSEMITE ST STE 1000 |
| Manufacturer City | GREENWOOD VILLAGE CO 80111 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80111 |
| 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 | 2019-02-15 |
| Model Number | PMA-GP-BAY |
| Catalog Number | 109860601 |
| Lot Number | UNKNOWN |
| 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 | 2019-02-15 |