MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED FLEXICOUPLER AND JELLY TAB COMBO PACK

Model Number	011445
Medical Device Problem Code	Component or Accessory Incompatibility (2897)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Part 011445 flexicoupler and jelly tab combo pack - the customer reported: the earmuffs that we use for the hearing screen, the sticky part is extremely sticky and is very difficult to get off the patient.We used wet wipes to help take it off from the skin.Patient had a red ring around his right ear.
Additional Manufacturer Narrative
Initial report ref natus complaint#(b)(4) (related to uf/importer report # (b)(4)).15-feb-2024 -the customer was sent a adverse event questionnaire and was requested to confirm if the product will be returned for evaluation.Further investigation to be carried out.
Event or Problem Description
Part 011445 flexicoupler and jelly tab combo pack - the customer reported: the earmuffs that we use for the hearing screen, the sticky part is extremely sticky and is very difficult to get off the patient.We used wet wipes to help take it off from the skin.Patient had a red ring around his right ear.
Additional Manufacturer Narrative
Follow up report 001 ref natus complaint# (b)(4) (related to uf/importer report # (b)(4).28-feb-2024 -received the questionnaire from the customer.(b)(4) attempts have been made to the customer, in relation to getting the affected product returned to natus for evaluation.Attempts were made on february 28th, march 20th, april 11th, and april 15th and no response to date.Further investigation to be carried out.
Event or Problem Description
Part 011445 flexicoupler and jelly tab combo pack - the customer reported: the earmuffs that we use for the hearing screen, the sticky part is extremely sticky and is very difficult to get off the patient.We used wet wipes to help take it off from the skin.Patient had a red ring around his right ear.
Additional Manufacturer Narrative
Follow up report 002 ref natus complaint#(b)(4).Update to section d4.- udi# (b)(4).Section h10.Includes (related report # (b)(4)).No further follow up action has been recorded or cross referenced in this complaint for at least 45 days since the customer was last provided with troubleshooting information.The customer has not called back for additional troubleshooting or to confirm this issue is ongoing.Review of customer's account found no additional related calls.Complaint will be closed but may require future action if trending so prescribes.Per doc-(b)(4); rev c algo 5 risk analysis.Hazard id 9.1 - skin irritant used in earphone construction.Earphone causes skin irritation.Effects (harm) - biological reaction on user/patient b-ra rating = low the hazard(s) identified have been evaluated and found to be in compliance with a known standard.As noted in qms-000018, hazards that have been evaluated and found to be in compliance with known standards can be presumed to be consistant with an acceptable level of risk, yielding an acceptable risk / benefit to the patient or user.The certificate of analysis (coa).And dhr data were reviewed.No issues noted.Failure confirmed: no.Investigation result code: neuro sbu|no response from customer.

• Brand Name: FLEXICOUPLER AND JELLY TAB COMBO PACK
• Common Device Name: FLEXICOUPLER AND JELLY TAB COMBO PACK
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; dba excel-tech ltd.; 2568 bristol circle; oakville, ontarios, L6H 5 S1; CA L6H 5S1
• Manufacturer (Section G): NATUS MANUFACTURING LIMITED; ida business park; gort; galway h91pd92, ; EI
• Manufacturer Contact: gráinne walsh ; dba excel-tech ltd.; 2568 bristol circle; oakville, ontarios, L6H 5-S1 ; CA L6H 5S1
• MDR Report Key: 18740621
• Report Number: 9612330-2024-00014
• Device Sequence Number: 15015090
• Product Code: GWJ
• UDI-Device Identifier: 00382830001885
• UDI-Public: 00382830001885
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2025
• Device Model Number: 011445
• Device Catalogue Number: 011445
• Device Lot Number: N082523-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2024
• Supplement Date Received by Manufacturer: 02/12/2024; Not provided
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 04/18/2024; 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 8 DA
• Patient Sex: Male
• Patient Weight: 3 KG