NA 72200634Recalls & reported problems

Smith & Nephew, Inc. · PERINEAL POST PAD 1 · Class 1

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010578129), received between Jul 17, 2024 and Jul 17, 2024 — 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

Hyperresponsive to stimuli1
Inflammation1
Laceration(s)1
Necrosis1
Skin Tears1

Recent adverse event reports

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

InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A CUSTOMER COMPLAINED AFTER FINDING THEY HAD A 3CM CUT OF THE TOP OF THEIR LEG/GROIN AREA FOLLOWING A HIP ARTHROSCOPY IN WHICH THE HIP DISTRACTOR WITH PERINEAL PAD WAS USED. THE INJURY WAS NOT DETECTED UNTIL THE PATIENT WENT HOME. FURTHER COMPLICATIONS WERE REPORTED: THE LEFT LABIA MAJORA WAS BADLY SWOLLEN, THE SKIN RIPPED AND CAME AWAY. THERE WAS EVIDENCE OF BLACK NECROSIS ON THE LABIA, AND THE INJURIES EXTENDED TOWARDS THE PERINEAL AREA. (ARTHROSCOPY WAS ON LEFT HIP).
Patient problems: Hyperresponsive to stimuli; Inflammation; Laceration(s); Necrosis; Skin Tears
MAUDE report 19763125 ↗

Device details

UDI-DI	`03596010578129`
Brand	NA
Model	72200634
Company	Smith & Nephew, Inc.
Product code	KQZ · COMPONENT, TRACTION, NON-INVASIVE
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 7, 2023

Device type (GMDN): Surgical counter-traction post

A cylindrical rod designed to be attached to an operating table or extension device to function as a support to counter the pulling of the traction being applied to a patient's body part (e.g., leg, pelvis) during an orthopaedic surgical procedure (e.g., hip arthroplasty, pelvic reconstruction); it is typically placed against the perineal region [referred to as perineal post] or leg bones (e.g., femur, tibia). It is available in various diameters and lengths and is typically padded. This is a reusable device.

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All COMPONENT, TRACTION, NON-INVASIVE devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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