MAUDE Adverse Event Report: NATUS MANUFACTURING LIMITED DISPOSABLE TECA CONCENTRIC NEEDLE; ELECTRODE

Model Number S53153

Device Problem Contamination (1120)

Patient Problem Cellulitis (1768)

Event Date 05/05/2016

Event Type  malfunction  

Manufacturer Narrative

Review of device history record has been completed.No untoward issues in the manufacturing of lot 49e/15/t.Cert of irradiation was reviewed, all parameters are compliant and product in question was sterilised within the correct parameters.Device not returned to manufacturer.

Event Description

Patient developed cellulitus post procedure using teca concentric needle electrodes.Physician stated "the patient in question had an electromyography performed on the (b)(6) 2016.The needle session points were anterior tibialis, medical gastrocnemius, vastus lateralis as well as paraspinal.He reported a painful swollen inflamed leg, was treated with oral antibiotics and subsequently admitted for a diagnosis of cellulitis.When i saw him, the leg was typical of cellulitis, although it was not at the needle insertion points but the upper limit of the inflammation was approximately 5cm below the lowest of the insertion points.The insertion points in vastus lateralis and paraspinal muscles did not show any inflammation.The order of the needle insertion was from distal to proximal.The needle did not appear unusual, the packaging did not seem to have been tampered with and the performance of the test was the same as always.After hospitalisation, his infection is now completely cleared up, though there is still some swelling that persists in the leg.".

Manufacturer Narrative

The following has been corrected: date of this report - corrected to 06/13/2016 (when reported to company) from 11/07/2016.Customer has been contacted to provide the rest of the required information.We are in the process of gathering additional information.A letter listing outstanding information has been sent to customer to obtain additional information in order to submit follow up report and/or explain why required information was not provided and steps taken to obtain such information.

• Brand Name: DISPOSABLE TECA CONCENTRIC NEEDLE
• Type of Device: ELECTRODE
• Manufacturer (Section D): NATUS MANUFACTURING LIMITED; ida business park; gort; galway, connaught H91PD 92; EI H91PD92
• Manufacturer (Section G): NATUS MANUFACTURING LIMITED; ida business park; gort; galway, connaught H91PD 92; EI H91PD92
• Manufacturer Contact: michael galvin ; ida business park; gort; galway, connaught H91PD-92 ; EI H91PD92 ; 9164700
• MDR Report Key: 5781651
• MDR Text Key: 49127599
• Report Number: 3005581270-2016-00004
• Device Sequence Number: 1
• Product Code: GXZ
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K112034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: S53153
• Device Catalogue Number: S53153
• Device Lot Number: 49F/15/T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other