MAUDE Adverse Event Report: COSMAN MEDICAL; PROBE, RADIOFREQUENCY LESION

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

Patient Problems Bruise/Contusion (1754); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943)

Event Type  Injury  

Manufacturer Narrative

Expiration date ni: event date: (b)(6).

Event Description

A report was received that a patient developed raised erythematous skin lesion which was weepy for 2 to 3 weeks associated with itching and bruising.The symptoms took 6 weeks to settle down.A dermatologist's opinion was obtained which suggested contact dermatitis and ruled out any allergic testing straight away as symptoms were improving.It is unknown if any medical treatment was provided.

Manufacturer Narrative

A report was received that further information cannot be obtained.

Event Description

A report was received that a patient developed raised erythematous skin lesion which was weepy for 2 to 3 weeks associated with itching and bruising.The symptoms took 6 weeks to settle down.A dermatologist's opinion was obtained which suggested contact dermatitis and ruled out any allergic testing straight away as symptoms were improving.It is unknown if any medical treatment was provided.

• Brand Name: NI
• Type of Device: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): COSMAN MEDICAL; 22 terry ave; burlington MA 01803
• Manufacturer (Section G): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 7527337
• MDR Text Key: 108693465
• Report Number: 3006630150-2018-01701
• Device Sequence Number: 1
• Product Code: GXI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K060799
• 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: 05/24/2018

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: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2018
• Initial Date FDA Received: 05/18/2018
• Supplement Dates Manufacturer Received: 05/21/2018
• Supplement Dates FDA Received: 05/24/2018
• 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