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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT TRIAL BODY SZ 16 + PRSTHSS, HP, SM-CNSTRND, MTL/CRMC/PLYMR, CMNTD R NN-PRS, NCMNTD

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SMITH & NEPHEW, INC. REDAPT TRIAL BODY SZ 16 + PRSTHSS, HP, SM-CNSTRND, MTL/CRMC/PLYMR, CMNTD R NN-PRS, NCMNTD Back to Search Results
Model Number 71354632
Device Problem Break
Event Date 06/01/2020
Event Type  Malfunction  
Event Description

It was reported that during an unknown procedure, the item was found broken. No injuries or surgical delays were reported. No information about backup devices was provided.

 
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Brand NameREDAPT TRIAL BODY SZ 16 +
Type of DevicePRSTHSS, HP, SM-CNSTRND, MTL/CRMC/PLYMR, CMNTD R NN-PRS, NCMNTD
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
sarah freestone
1450 brooks road
memphis , TN 38116
0447940038
MDR Report Key10193952
Report Number1020279-2020-02723
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 06/25/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/25/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number71354632
Device Catalogue Number71354632
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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