MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION cannulaRFK; PROBE, RADIOFREQUENCY LESION

Model Number RFK-C101018S-P

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Skin Irritation (2076)

Event Date 07/05/2018

Event Type  Injury  

Event Description

A report was received that a patient developed discreet circles of redness at the point of needle entry and it was not a generalized rash.The physician prepped the patient's skin with chlorhex.No further information can be obtained, as it was not provided by the facility.

Event Description

A report was received that a patient developed discreet circles of redness at the point of needle entry and it was not a generalized rash.The physician prepped the patient's skin with (b)(6).No further information can be obtained, as it was not provided by the facility.

• Brand Name: cannulaRFK
• Type of Device: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): COSMAN MEDICAL, LLC; 22 terry avenue; ,; burlington MA 01803
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; ,; valencia, CA 91355 ; 6619494863
• MDR Report Key: 7742921
• MDR Text Key: 115809738
• Report Number: 3006630150-2018-60458
• Device Sequence Number: 1
• Product Code: GXI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K050084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RFK-C101018S-P
• Device Catalogue Number: RFK-C101018S-P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2018
• 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): Required Intervention