MAUDE Adverse Event Report: SIVANTOS SP. Z O.O. SIGNIA; MOTION SP 2PX

Catalog Number	10942735
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Ear infection (4813)
Date of Event	06/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We were made aware, that our electronic submissions failed and not received by fda.Car_s-us_2024_008 is opened to address this issue and this report was electronically resubmitted on (03/05/2023).
Event or Problem Description
In this event, patient in france with a history of otitis developed otitis three times in her left ear after wearing motion sp 2 px hearing aids with earmolds.The ent did not think the otitis originated from the devices, but the infection appears to feed on the occlusion of the ear canals by the earmolds.Earmolds initially made of acrylic and remade with silicone.The same type of hearing aids and earmolds are distributed in the u.S.As proof of design the materials are tested for biocompatiblity according to iso 10993-1.The device was not returned; it is speculated that the on-going infection which was previously had by the user was additionally contributed when using the earmolds which closed the ear canals.This allowed for the build-up of bacterium against the users skin.The fact that the otitis occurs with different items (earmolds made of silicone and acrylic resin) also leads to the conclusion that the otitis is not related to the used material.

• Brand Name: SIGNIA
• Common Device Name: MOTION SP 2PX
• Manufacturer (Section D): SIVANTOS SP. Z O.O.; baltycka 6; poznan, wielkopolskie 61-01 3; PL 61-013
• Manufacturer Contact: la-shaunda joseph ; 101 wood avenue south; 7th floor; iselin, NJ 08830 ; 5617859321
• MDR Report Key: 18838693
• Report Number: 3012119662-2024-00004
• Device Sequence Number: 17927275
• Product Code: OSM
• UDI-Device Identifier: 04038953855855
• UDI-Public: 04038953855855
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2024

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 10942735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White