FDA Adverse Event Injury Summary report: N

ULTRAGUIDECTR

MDR report key: 17998233 · Received October 24, 2023

Report

Report Number: 3013479847-2023-00006
Event Type: Injury
Date Received: October 24, 2023
Date of Event: September 5, 2023
Report Date: October 24, 2023
Manufacturer: SONEX HEALTH
Product Code: LXH
UDI-DI: 00860002094700
PMA / PMN Number: K192873
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NH, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, THE LOT NUMBER WAS NOT REPORTED AND THEREFORE A REVIEW OF DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. INFECTION IS REFERENCED IN THE ULTRAGUIDECTR INSTRUCTIONS FOR USE AS A POSSIBLE COMPLICATION. NO DEVICE MALFUNCTION WAS REPORTED.

Description of Event or Problem · 0

THE PATIENT HAD RIGHT HAND CARPAL TUNNEL RELEASE USING ULTRAGUIDECTR WITH ULTRASOUND GUIDANCE. 13 DAYS LATER THE PATIENT WENT TO EMERGENCY DEPARTMENT WITH A RIGHT HAND WRIST PAIN, PAIN WITH MOVEMENT, AND RIGHT WRIST SEROMA A SITE OF INCISION (CONFIRMED BY CT). IRRIGATION AND DRAINAGE WERE PERFORMED AT BEDSIDE. METHICILLIN SENSITIVE STAPHYLOCOCCUS AUREUS (MSSA) INFECTION NOTED. THE NEXT DAY THE PATIENT WAS PRESENTED TO THE CLINIC WITH SYMPTOMS CONCERNING OF FLEXOR TENOSYNOVITIS OF RIGHT SMALL AND INDEX FINGERS. THE PATIENT WAS ADMITTED FOR IV ANTIBIOTICS. SYMPTOMS IMPROVED BUT DID NOT COMPLETELY RESOLVE. TWO DAYS LATER THE PATIENT WAS TAKEN TO THE OPERATING ROOM TO OPEN THE FLEXOR SHEATHS OF THE SMALL AND INDEX FINGER. MURKY FLUID ENCOUNTERED. NO GROWTH WAS NOTED. DIAGNOSIS WAS INFECTIOUS FLEXOR TENOSYNOVITIS. NO DEVICE MALFUNCTION WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1582062	ULTRAGUIDECTR	CARPAL TUNNEL RELEASE SYSTEM	LXH	SONEX HEALTH	600112-001		00860002094700

Patients

Seq	Age	Sex	Outcome	Treatment
1	58 YR	Male	Required Intervention