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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN COVIDIEN STAPLER SKIN 35 MM WIDE ROTATING STAPLER, SURGICAL

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COVIDIEN COVIDIEN STAPLER SKIN 35 MM WIDE ROTATING STAPLER, SURGICAL Back to Search Results
Model Number PRW35
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Fever (1858); Unspecified Infection (1930)
Event Date 11/14/2019
Event Type  Injury  
Event Description

Pt had colon surgery on (b)(6) 2019. On (b)(6) 2019, pt developed a fever of 103. 1. Abd was cultured and grew yeast. The pt was taken back to the operating room on (b)(6). Op findings include further dissection into the pelvis; however, revealed some fibrillar purulent exudate around the drain and much denser adhesions. Fda safety report id# (b)(4).

 
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Brand NameCOVIDIEN STAPLER SKIN 35 MM WIDE ROTATING
Type of DeviceSTAPLER, SURGICAL
Manufacturer (Section D)
COVIDIEN
MDR Report Key9865204
MDR Text Key184851071
Report NumberMW5093871
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 03/18/2020
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 NumberPRW35
Device Catalogue Number4100
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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