FDA Adverse Event Injury Summary report: N

ON-Q PAIN PUMP

MDR report key: 2552728 · Received April 24, 2012

Report

Report Number: 2026095-2012-00063
Event Type: Injury
Date Received: April 24, 2012
Date of Event: March 16, 2006
Report Date: April 5, 2012
Manufacturer: I-FLOW CORP.
Product Code: MEB
PMA / PMN Number: K063530
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

METHOD: NO PRODUCT WAS RETURNED FOR EVAL AND INVESTIGATION. RESULTS: THE INFO CONTAINED IS FROM LEGAL DOCUMENTS SERVED ON I-FLOW CORP. 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. CONCLUSION: AS THIS COMPLAINT WAS CREATED FROM A LAWSUIT SERVED ON I-FLOW, NO CUSTOMER CONTACT CAN BE MADE AT THIS TIME DUE TO THE PENDING LITIGATION. AS OF 11/09/2006, I-FLOW HAS UPDATED ITS 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 POSSIBLE ASSOCIATION BETWEEN CONTINUOUS INTRA-ARTICULAR INFUSIONS (PARTICULARLY WITH BUPIVACAINE) AND THE SUBSEQUENT DEVELOPMENT OF CHONDROLYSIS." (DFU 1307011). ON 08/08/2007, 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: 0.5% MARCAINE WITHOUT EPINEPHRINE. FILL VOLUME: UNK. FLOW RATE: UNK. PROCEDURE: ARTHROSCOPIC SURGERY. CATHPLACE: SHOULDER JOINT. REF: 2026095-2012-00062 (B)(4). PT ALLEGES CHONDROLYSIS FOLLOWING PLACEMENT OF AN I-FLOW PAINBUSTER AFTER SURGERY ON (B)(6) 2006.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other