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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SMARTSET GHV GENTAMICIN 40G BONE CEMENT : BONE CEMENT

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DEPUY ORTHOPAEDICS, INC. 1818910 SMARTSET GHV GENTAMICIN 40G BONE CEMENT : BONE CEMENT Back to Search Results
Catalog Number 3095040
Device Problems Device Damaged Prior to Use (2284); Packaging Problem (3007)
Patient Problem Not Applicable (3189)
Event Date 07/11/2019
Event Type  Malfunction  
Manufacturer Narrative

Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

After opening box, cement pouch was not sealed and powder falling out as per attached image. New packets opened. No ae to the patient, 5 minutes delay to the surgery.

 
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Brand NameSMARTSET GHV GENTAMICIN 40G
Type of DeviceBONE CEMENT : BONE CEMENT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw 46582
Manufacturer (Section G)
DEPUY CMW - 9610921
cornford rd
blackpool FY4 4 QQ
UK FY4 4QQ
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, IN 19380-0988
6103142063
MDR Report Key8836449
MDR Text Key152794596
Report Number1818910-2019-99520
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 07/11/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/29/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2020
Device Catalogue Number3095040
Device LOT Number8801948
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/09/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/17/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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