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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LIMITED CP1000 STANDARD RECHARGEABLE BATTERY MODULE PACKED (SAND); NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
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COCHLEAR LIMITED CP1000 STANDARD RECHARGEABLE BATTERY MODULE PACKED (SAND); NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number Z544553
Device Problems No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)
Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/28/2022
Event Type  Injury  
Event Description
It was reported that the patient had swallowed the battery.Additional information has been requested but has not been made available as of the date of this report.This report is submitted on october 26, 2022.
 
Event Description
Per the clinic, the patient underwent a surgery on (b)(6) 2022 to remove the battery.
 
Event Description
Correction: this mdr was a duplicate.Any further information will be provided with report number: 6000034-2022-03363.
 
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Brand Name
CP1000 STANDARD RECHARGEABLE BATTERY MODULE PACKED (SAND)
Type of Device
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR LIMITED
1 university avenue
macquarie university
nsw 2109
AS  2109
MDR Report Key15671935
MDR Text Key302397785
Report Number6000034-2022-03191
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 03/17/2023,02/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberZ544553
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/17/2023
Distributor Facility Aware Date02/27/2023
Event Location Other
Date Report to Manufacturer02/27/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age10 YR
Patient SexMale
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