MAUDE Adverse Event Report: NISSHA MEDICAL TECHNOLOGIES LIMITED BOSTON SCIENTIFIC; NEUTRAL ELECTRODE

Model Number DGP-PMC2

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 09/09/2023

Event Type  Injury  

Manufacturer Narrative

Due to no lot numbers being provided at this time it is not possible to carry out a manufacturing review or full investigation.

Event Description

It was reported that a patient burn from a ground pad during a radiofrequency ablation procedure.Rep found out about this last thursday, 21 september 2023.Date of occurrence was (b)(6) 2023.Patient is being treated with antibiotics.After learning more about the patient, the account let rep know the ground pad did not adhere very well to the skin.Patient was prescribed antibiotics.Due to intervention ( prescription antibiotics) to preclude permanent damage, nmt is reporting this event.

• Brand Name: BOSTON SCIENTIFIC
• Type of Device: NEUTRAL ELECTRODE
• Manufacturer (Section D): NISSHA MEDICAL TECHNOLOGIES LIMITED; torbay business park; woodview rd; paington, devon TQ4 7 HP; UK TQ4 7HP
• Manufacturer (Section G): NISSHA MEDICAL TECHNOLOGIES LTD; torbay business park; woodview rd; paignton, devon TQ4 7 HP; UK TQ4 7HP
• Manufacturer Contact: jessica potter ; 400 exchange st; buffalo, NY 14204 ; 7168496367
• MDR Report Key: 17987603
• MDR Text Key: 326300733
• Report Number: 3008933393-2023-00015
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/23/2023

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
• Device Model Number: DGP-PMC2
• Device Catalogue Number: 4012997C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2023
• Initial Date FDA Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention