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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE GENERAL SURGERY PACK (DSDCB)468 GENERAL SURGERY TRAY (KIT)

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MEX03 MEXICO-JUAREZ PRESOURCE GENERAL SURGERY PACK (DSDCB)468 GENERAL SURGERY TRAY (KIT) Back to Search Results
Model Number SBAC2DSDCC
Device Problem Nonstandard Device (1420)
Patient Problems Hematoma (1884); Unspecified Infection (1930); Sepsis (2067); Fluid Discharge (2686)
Event Date 12/15/1979
Event Type  Injury  
Manufacturer Narrative

The complaint was forwarded to the manufacturing facility where it is currently still under investigation. A follow-up report will be filed once the results have been completed.

 
Event Description

Customer informed cardinal health that they have noticed an increase in infections and believes it¿s in conjunction with the gown recall. Patient had a left hip hemi-arthroplasty on (b)(6) 2019. On (b)(6) 2019 persistent drainage. On (b)(6) 2019 persistent drainage. On (b)(6) 2020 persistent drainage, and elevated esr, crp, and white blood count. On (b)(6) 2020 patient diagnosed with sepsis due to infected hematoma, patient with + troponins immediately post-op. On (b)(6) 2020 irrigation and debridement of postsurgical wound including evacuation of hematoma. On (b)(6) 2020 patient started on vancomycin, cefepime, and levaquin while inpatient. On (b)(6) 2020 patient discharged on levofloxacin 750mg oral daily for 7 days. On (b)(6) 2020¿patient recovering well status post left hip infected hematoma irrigation and debridement. This case used a cardinal health general surgery pack sbac2dsdcc that contained either gown a9541nae or 90370nba.

 
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Brand NameGENERAL SURGERY PACK (DSDCB)468
Type of DeviceGENERAL SURGERY TRAY (KIT)
Manufacturer (Section D)
MEX03 MEXICO-JUAREZ PRESOURCE
c. arcadia 1580 , col. terraza
cd.juarez , chihuahua CP 32 599
MX CP 32599
Manufacturer (Section G)
MEX03 MEXICO-JUAREZ PRESOURCE
c. arcadia 1580 , col. terraza
cd.juarez , chihuahua CP 32 599
MX CP 32599
Manufacturer Contact
patricia tucker
1500 waukegan rd
waukegan, IL 60085
8478874151
MDR Report Key9862948
MDR Text Key196546102
Report Number1423537-2020-00441
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 03/23/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/20/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSBAC2DSDCC
Device Catalogue NumberSBAC2DSDCC
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/20/2020 Patient Sequence Number: 1
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