FDA Adverse Event Injury Summary report: N

ON-Q PUMP

MDR report key: 2092611 · Received May 5, 2011

Report

Report Number: 2026095-2011-00131
Event Type: Injury
Date Received: May 5, 2011
Date of Event: April 7, 2004
Report Date: April 8, 2011
Manufacturer: I-FLOW CORP.
Product Code: MEB
PMA / PMN Number: UNK
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

METHOD: NO PRODUCT WAS RETURNED FOR EVAL AND INVESTIGATION. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. RESULTS: THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. THE REPORT DID NOT PROVIDE ANY SPECIFIC INFO CONCERNING THE PROCEDURE, OR OTHER PARTICULARS OF THE ALLEGED INCIDENT. WITHOUT THE ACTUAL PRODUCT OR DETAILS OF THE INCIDENT, AN ANALYSIS CANNOT BE CONDUCTED. ON ON-Q PUMP DIRECTIONS FOR USE (DFU) CONTAIN A WARNING THAT STATES: "AVOID PLACING THE CATHETER IN JOINT SPACES. ALTHOUGH THERE IS NO DEFINITIVE ESTABLISHED CAUSAL RELATIONSHIP, SOME LITERATURE HAS SHOWN AN POSSIBLE ASSOCIATION BETWEEN CONTINUOUS INTRA-ARTICULAR INFUSIONS (PARTICULARLY WITH BUPIVACAINE) AND THE SUBSEQUENT DEVELOPMENT OF CHONDROLYSIS." (DFU 1304265, REV. L). I-FLOW HAS ALSO PREPARED A TECHNICAL BULLETIN ENTITLED "WHAT WE KNOW ABOUT CHONDROLYSIS TODAY." (1303772, REV. E). IF ADD'L INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A F/U REPORT.

Description of Event or Problem · 1

DRUG/DILUENT: UNK. PROCEDURE: SHOULDER SURGERY. CATHPLACE: UNK. PT ALLEGEDLY DEVELOPED CARTILAGE DAMAGE FOLLOWING PLACEMENT OF A ON-Q PAINBUSTER PUMP AFTER SURGERY ON (B)(6) 2004.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	27 YR		Other