FDA Adverse Event Injury Summary report: N

TMAX

MDR report key: 3944717 · Received July 18, 2014

Report

Report Number: 1643264-2014-00016
Event Type: Injury
Date Received: July 18, 2014
Report Date: June 25, 2014
Manufacturer: OKLAHOMA CITY MANUFACTURING SITE
Product Code: FWZ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THE CUSTOMER INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS. HOWEVER, REVIEW OF THE IFU SHOWS THAT THIS DEVICE WAS MANUFACTURED WITH SOME TYPE OF PAD. (B)(4).

Description of Event or Problem · 1

THREE PATIENTS REPORTED THE SAME COMPLAINTS TO THE HOSPITAL (B)(6). AFTER ARCR (ARTHROSCOPIC ROTATOR CUFF REPAIR) OPERATIONS USING T-MAX, THE PATIENTS EXPERIENCED SWELLING ON THEIR BACK AND HIP. THE PATIENTS CPK LEVELS WERE APPROXIMATELY 10000 ~ 15000. AFTER THE INCIDENT, SNEKK SALES REP TOLD THE FACILITY TO PUT A CUSHION MATERIAL BETWEEN THE PATIENT AND THE DEVICE. THE PATIENTS WERE INSERTED AN INTRAVENOUS DRIP FOR 3 OR 4 DAYS WITH CAREFUL ATTENTION TO CPK. WE HAVE NOT RECEIVED ANY OTHER INTERVENTION INFORMATION ASIDE FROM THE INTRAVENOUS DRIP. THE SWELLING WAS NOTICED AFTER THE PROCEDURES WERE COMPLETED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
422834	TMAX	T-MAX, ESCHMANN/JAP, TABLES	FWZ	OKLAHOMA CITY MANUFACTURING SITE	72200481

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R