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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SEPTOPAL BEADS 30; STERILIZER, GLASS BEAD
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SMITH & NEPHEW, INC. SEPTOPAL BEADS 30; STERILIZER, GLASS BEAD Back to Search Results
Catalog Number 120148
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Metal Related Pathology (4530)
Event Date 06/06/2008
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference number: (b)(4).
 
Event Description
It was reported that, after bhr implant surgery performed in (b)(6) 2003, due to severe pain, a revision surgery was performed in (b)(6) 2011, there is a diagnosis for metallosis, and there is still a lot of pain, and respiratory issues reported, patient is waiting for another surgery.
 
Manufacturer Narrative
Additional information was received that identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.
 
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Brand Name
SEPTOPAL BEADS 30
Type of Device
STERILIZER, GLASS BEAD
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key11456806
MDR Text Key239077435
Report Number1020279-2021-01956
Device Sequence Number1
Product Code ECC
UDI-Device Identifier03596010612045
UDI-Public3596010612045
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup
Report Date 07/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number120148
Device Lot Number29503
Was Device Available for Evaluation? No
Date Manufacturer Received07/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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