MAUDE Adverse Event Report: ACCLARENT, INC. UNKNOWN

Model Number N/A

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

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Type  Injury  

Manufacturer Narrative

The age and weight of the patient are not known.The event date is not known.The physician reported that the event happened several years ago.The exact balloon type is not known.No acclarent devices are available to be returned for evaluation as the exact date of the event is not known and no other details are available.If additional information is received regarding this report, a supplemental report will be filed.Complaint#: (b)(4).

Event Description

Acclarent was informed of an event on (b)(6) 2016, of a procedure using an acclarent balloon in which the adverse event was a cerebrospinal fluid (csf) leak.The date of the event is unknown as the physician stated that it was a csf leak and it happened several years ago.The information at the time of the event was relayed through the nurse.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

• Brand Name: UNKNOWN
• Type of Device: UNKNOWN
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology drive; irvine CA
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497899383
• MDR Report Key: 5484839
• MDR Text Key: 39843885
• Report Number: 3005172759-2016-00005
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: N/A
• Device Catalogue Number: 9999999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other