FDA Adverse Event Injury Summary report: N

ON-Q PAIN PUMP

MDR report key: 2722718 · Received August 29, 2012

Report

Report Number: 2026095-2012-00221
Event Type: Injury
Date Received: August 29, 2012
Date of Event: April 28, 2005
Report Date: November 18, 2011
Manufacturer: I-FLOW, LLC
Product Code: MEB
PMA / PMN Number: K063530
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

METHOD: NO PRODUCT WAS RETURNED FOR EVALUATION AND INVESTIGATION. 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 U.S. FOOD AND DRUG ADMINISTRATION. NO FURTHER INVESTIGATION WILL BE CONDUCTED. CONCLUSION: AS THIS COMPLAINT WAS CREATED FROM A LAWSUIT SERVED ON I-FLOW OR THE THREAT OF A LAWSUIT, NO CUSTOMER CONTACT CAN BE MADE AT THIS TIME DUE TO THE PENDING OR THREATENED LITIGATION." AS OF 11/9/2006 I-FLOW UPDATED THE ON-Q PUMP DIRECTIONS FOR USE (DFU), TO INCLUDE THE FOLLOWING IN THE WARNINGS SECTION: "AVOID PLACING THE CATHETER IN JOINT SPACES. ALTHOUGH THERE IS NO DEFINITIVE ESTABLISHED CAUSAL RELATIONSHIP, SOME LITERATURE HAS SHOWN A POSSIBLE ASSOCIATED BETWEEN CONTINUOUS INTRA-ARTICULAR INFUSIONS (PARTICULARLY WITH BUPIVACAINE) AND THE SUBSEQUENT DEVELOPMENT OF CHONDROLYSIS." (DFU 1307011). ON 8/8/2007, I-FLOW HAS ALSO PREPARED A TECHNICAL BULLETIN ENTITLED "WHAT WE KNOW ABOUT CHONDROLYSIS TODAY." (1303722, REV. E).

Description of Event or Problem · 1

DRUG/DILUENT: UNKNOWN. FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: LEFT SHOULDER ARTHROSCOPY. CATHPLACE: LEFT SHOULDER. PATIENT ALLEGES CHONDROLYSIS FOLLOWING PLACEMENT OF AN ON-Q PAINBUSTER AFTER SURGERY ON (B)(6) 2005.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ON-Q PAIN PUMP	ELASTOMERIC PUMP	MEB	I-FLOW, LLC	PM014	512898

Patients

Seq	Age	Sex	Outcome	Treatment
1	42 YR		Other