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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION AVAULTA BIOSYNTHETIC SUPPORT SYSTEM
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SOFRADIM PRODUCTION AVAULTA BIOSYNTHETIC SUPPORT SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/26/2023
Event Type  Injury  
Manufacturer Narrative
H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
 
Event Description
It was reported by the patient's attorney that as a result of having the product implanted, the patient has experienced pain, injury, disability, and impairment.
 
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Brand Name
AVAULTA BIOSYNTHETIC SUPPORT SYSTEM
Type of Device
AVAULTA BIOSYNTHETIC SUPPORT SYSTEM
Manufacturer (Section D)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux 01600
FR  01600
MDR Report Key18130728
MDR Text Key328040090
Report Number1018233-2023-08095
Device Sequence Number1
Product Code OTP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082571
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type Other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/14/2023,11/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/14/2023
Distributor Facility Aware Date10/26/2023
Event Location Other
Date Manufacturer Received10/26/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexFemale
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