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 2018-10-02 for RF GROUNDING PAD DISPOSABLE WITH CORD PMA-GP-BAY 109860601 manufactured by Avanos Medical Inc..
[122453600]
The sample is reported to be available, but has not yet been received by the manufacturer. A review of the device history record is not possible as no lot number was provided. All information reasonably known as of 01-oct-2018. 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 (b)(4). Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[122453601]
It was reported that during the second burn the pain management generator (pmg) gave a temperature error message. Additional information received (b)(6) 2018 stated the first round of ablation was successful. The location of the grounding pad was the right flank. The procedure was a lumbar radio frequency (rf) ablation. An unknown error message was noted. The physician was able to continue with procedure. During the second burn, the pmg gave a temperature error message, exact message unknown. Staff heard a "crackling" noise and a burn was noticed under patient's right flank. The grounding pad was removed from the right flank and replaced with a new grounding pad. A second grounding pad was placed on the upper thigh and the procedure was completed without issue. A wound care nurse was consulted for the burn. It was unknown what severity or if treatment was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011270181-2018-00044 |
| MDR Report Key | 7928124 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-02 |
| Date of Report | 2018-12-06 |
| Date of Event | 2018-09-06 |
| Date Mfgr Received | 2018-12-06 |
| Date Added to Maude | 2018-10-02 |
| 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 |
| 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 30004 |
| Manufacturer Country | US |
| Manufacturer Postal | 30004 |
| Manufacturer Phone | 4704485444 |
| Manufacturer G1 | BAYLIS MEDICAL COMPANY, INC. |
| Manufacturer Street | 2645 MATHESON BLVD. EAST |
| Manufacturer City | MISSISSAUGA, ONTARIO |
| Manufacturer Country | US |
| 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 | 2018-10-02 |
| Returned To Mfg | 2018-10-26 |
| Model Number | PMA-GP-BAY |
| Catalog Number | 109860601 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-10-02 |