• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS DRAD DORS PL 3H L TI WIDE 58MM SAMP PLATE, FIXATION, BONE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITH & NEPHEW, INC. EVOS DRAD DORS PL 3H L TI WIDE 58MM SAMP PLATE, FIXATION, BONE Back to Search Results
Catalog Number 71195170
Device Problems Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/04/2020
Event Type  Malfunction  
Event Description

It was reported that, whilst the label and actual part references to 71195170, the actual product is 71195169 instead of 71195170. As this was noticed upon inspection, no case was involved.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEVOS DRAD DORS PL 3H L TI WIDE 58MM SAMP
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
1450 brooks rd.
memphis, TN 38116
5123913905
MDR Report Key10766876
MDR Text Key214091247
Report Number1020279-2020-05970
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeSA
PMA/PMN NumberK140814
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/28/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/30/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number71195170
Device LOT Number20CT35339
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured03/02/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-