FDA Adverse Event Injury Summary report: N

ON-Q PAIN PUMP

MDR report key: 3678910 · Received February 20, 2014

Report

Report Number: 2026095-2014-00021
Event Type: Injury
Date Received: February 20, 2014
Date of Event: May 18, 2006
Report Date: January 24, 2014
Manufacturer: I-FLOW LLC.
Product Code: MEB
PMA / PMN Number: K063530
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

METHOD: THE PRODUCT WAS NOT RETURNED FOR AN EVALUATION AND INVESTIGATION. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE THE DEVICE HISTORY RECORDS (DHR) COULD NOT BE REVIEWED. RESULTS: THE INFORMATION CONTAINED IS FROM LEGAL DOCUMENTS SERVED ON I-FLOW, LLC. THE COMPLAINT WAS OPENED SO THAT A MEDICAL DEVICE REPORT (MDR) CAN BE FILED WITH THE US FOOD AND DRUG ADMINISTRATION. NO FURTHER INVESTIGATION WILL BE CONDUCTED. CONCLUSIONS: AS THIS COMPLAINT AS CREATED FROM A LAWSUIT SERVED ON I-FLOW, LLC. NO CUSTOMER CONTACT CAN BE MADE AT THIS TIME DUE TO THE PENDING OR THREATENED LITIGATION. AS OF 11/09/2006 I-FLOW UPDATED THE ON-Q PUMP DIRECTION FOR USE (DFU). ON 08/08/2007, I-FLOW HAS ALSO PREPARED A TECHNICAL BULLETIN ENTITLED "WHAT WE KNOW ABOUT CHONDROLYSIS TODAY'. (1303722, REV. E). INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TRENT REPORTING SYSTEM.

Description of Event or Problem · 1

DRUG/DILUENT: 0.5 % MARCAINE. FILL VOLUME: NP. FLOW RATE: NP. PROCEDURE: ARTHROSCOPY OF RIGHT SHOULDER AND ENDOSCOPIC ANTERIOR LABRUM REPAIR WITH INTERIOR SHIFT ON THE RIGHT SHOULDER. CATHPLACE: INTRA-ARTICULARE SPACE OF THE RIGHT SHOULDER. DATE OF SURGERY: (B)(6) 2006. PT ALLEGES DEGENERATION IN HIS RIGHT SHOULDER FOLLOWING PLACEMENT OF AN ON-Q PAINBUSTER AFTER SURGERY ON OR ABOUT (B)(6) 2006.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
107702	ON-Q PAIN PUMP	ELASTOMERIC PUMP	MEB	I-FLOW LLC.	UNK	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	NP		Other