MAUDE Adverse Event Report: I-FLOW CORP. LLC ON-Q PAINPUMP; ELASTOMETRIC PUMP

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

Patient Problems Cellulitis (1768); Unspecified Infection (1930)

Event Type  Injury  

Event Description

Fill volume: unk -anp.Flow rate: unk - anp.Procedure: c-section.Cathplace: incisional.A comment was posted on (b)(6) 2014 on (b)(6) of an incident regarding an infection which required the pt to be treated with antibiotics."i developed an infection on my stomach following a routine c-section.They placed an on-q pump (catheter that fed pain meds to my incision.) i developed cellulitis on my stomach close to my incision.The doctor discharged me at 9:00 am and gave me a prescription of antibiotics (keflex)." further info was not provided by the reporter/pt.Np: not provided.

Manufacturer Narrative

Method: the device is not available for return as the info obtained for this report was provided from a social media website.A review of the device history record (dhr) could not be conducted as no lot number was provided.Results: as a device was not available for an evaluation no methods were performed, therefore results cannot be obtained.Conclusions: as this complaint was created from a social media website at this time no further info has been provided by the reporter/pt.I-flow/kcc has reached out to the reporter/pt via the (b)(6) website where the incident was posted and is awaiting a response.At this time of this report, we have no received any additional info.If additional info is received pertinent to this incident i-flow will submit a follow-up report.Info from this incident has been included in our product complaint and mdr trend reporting systems.

• Brand Name: ON-Q PAINPUMP
• Type of Device: ELASTOMETRIC PUMP
• Manufacturer (Section D): I-FLOW CORP. LLC; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery, suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4117458
• MDR Text Key: 4936287
• Report Number: 2026095-2014-00180
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 08/22/2014
• Initial Date FDA Received: 09/19/2014
• 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
• Patient Outcome(s): Other