MAUDE Adverse Event Report: GN HEARING A/S GN RESOUND; HEARING AID

Model Number	EM,NC-HA-RF1-MP3P
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Localized Skin Lesion (4542)
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4)-encased micro-mold,3 pin,mp(b)(4) during normal wearing, the shell is suddenly broken and the external ear scratch.The device broke when using at home.The object was removed by the user and caused bleeding.The user has not experienced this before.The user has been in contact with a medical practioner and no treatment was given.The medical practioner commented- the ear looks not so serious and remember not to touch water.
Additional Manufacturer Narrative
(b)(4): case reported in (b)(6).This has been reported to (b)(6) authorities.This is a combined report- intial and follow up.Investigation has been completed.Root cause: no abnormity found about mfg process based on samples investigation, all manufacturing records and potential failure modes review (dhr, uv curing, thickness, etc.).More related to reliability issue based on customer usage for a while (2 years).
Additional Manufacturer Narrative
Sf (b)(6).Case reported in china.This has been reported to chinese authorities.This is a combined report- intial and follow up.Investigation has been completed.Root cause: no abnormity found about mfg process based on samples investigation, all manufacturing records and potential failure modes review (dhr, uv curing, thickness, etc.).More related to reliability issue based on customer usage for a while (2 years).22-jun-2022: national medical product administration in china requested results of the investigation of the device translated to chinese.The translation was provided on 22-jun-2022.No other updates to report.
Event or Problem Description
Xu zixiao 19709500-encased micro-mold,3 pin,mp(b)(6).During normal wearing, the shell is suddenly broken and the external ear scratch.The device broke when using at home.The object was removed by the user and caused bleeding.The user has not experienced this before.The user has been in contact with a medical practioner and no treatment was given.The medical practioner commented- the ear looks not so serious and remember not to touch water.

• Brand Name: GN RESOUND
• Common Device Name: HEARING AID
• Manufacturer (Section D): GN HEARING A/S; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• Manufacturer Contact: karen frisk ; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• MDR Report Key: 14431559
• Report Number: 3005650109-2022-00003
• Device Sequence Number: 6466158
• Product Code: OSM
• UDI-Device Identifier: 05708296140800
• UDI-Public: 05708296140800
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2022

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 Model Number: EM,NC-HA-RF1-MP3P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2022
• Supplement Date Received by Manufacturer: 04/24/2022
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Race: Asian