AVANOS PMP-100-NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00193493303939), received between Nov 14, 2022 and Nov 14, 2022 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED AN INFECTED WOUND REQUIRING A SKIN GRAFT, THE PLASTIC SURGEON HAD TO PERFORM A SKIN GRAFT. PATIENT STATUS LISTED AS RECOVERING. THE PATIENT UNDERWENT A GENICULAR NERVE RF [RADIO FREQUENCY] ABLATION. THE INFERIOR MEDIAL LESION (OVER THE MEDIAL BORDER OF THE UPPER TIBIA) SHOWED ERRATIC TEMPERATURE AND POWER READINGS. THE LESION WAS STOPPED AND RESTARTED SEVERAL TIMES WITH THE SAME OUTCOME. THE PROCEDURE WAS THEN ABANDONED. THERE WAS SOME INCREASED SWELLING NOTED AT THE TIME OF THE LESION. THE PATIENT HAD AN UNUSUAL AMOUNT OF POST PROCEDURE PAIN. THE PATIENT WAS CONTACTED VIA TELEPHONE AND ONLY COMPLAINED OF PAIN. THE WOUND STARTED TO BREAKDOWN AT THE PROCEDURE SITE AFTER A WEEK AND DEVELOPED A LARGE CAVITY BY THE SECOND WEEK. THE PROCEDURE SITE HAD BECOME INFECTED. THE PATIENT WAS REFERRED TO A PLASTIC SURGEON FOR FURTHER MANAGEMENT OF THE WOUND. THE GENERATOR ACTIVATION ONLY LASTED A MAXIMUM OF 30 SECONDS BEFORE GIVING AN ERROR MESSAGE, THE PROCEDURE WAS PERFORMED USING A 100MM NIMBUS NEEDLE. ADDITIONAL INFORMATION RECEIVED 04-NOV-2022 STATING THE PHYSICIAN WAS USING THE NIMBUS NEEDLE INSTEAD OF THE AVANOS RF CANNULA (LARGER LESION PREFERENCE)

  Patient problems: Pain; Post Operative Wound Infection; Swelling/ Edema; Unspecified Infection

  MAUDE report 15793014 ↗