MAUDE Adverse Event Report: I-FLOW CORP.

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 01/01/2007

Event Type  Injury  

Event Description

Fill volume: unk - anp, flow rate: unk- anp, procedure: laparoscopic rotator cuff repair, cathplace: shoulder.It was reported that a patient experienced shoulder issues further described as "never been right" and "popping, it sounds like bones rubbing together" following shoulder surgery (possibly laparoscopic rotator cuff repair) in 2007.The patient never follow-up with her surgeon.The patient did not have a nerve block.The catheter was placed in her shoulder.The patient no longer has the pump.Drug info and flow rate was asked but unk.

Manufacturer Narrative

Method: the product was not returned for an evaluation and investigation.The lot number was not provided; therefore, the device history records could not be reviewed.Results: as the device was not available for an evaluation, no methods were performed and testing results cannot be obtained.Conclusions: as limited info was provided by the reporter, the fill volume and user conditions of the device was not provided as well as the device info was not available.The patient reported that she is seeking legal counsel.This 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.Info from this incident has been included in our product complaint and mdr trend reporting systems.Trend info is used to identify the need for additional investigations.

• Brand Name: UNK
• Type of Device: UNK
• Manufacturer (Section D): I-FLOW CORP.; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery, ste 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4195999
• MDR Text Key: 5039659
• Report Number: 2026095-2014-00199
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DRUG: UNK - ANP