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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN SURGIPRO; MESH, SURGICAL, POLYMERIC
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COVIDIEN LP LLC NORTH HAVEN SURGIPRO; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number SMPL-01
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Fever (1858); No Code Available (3191)
Date of Event 07/22/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, 3 days after right inguinal hernia filled with sacral hemorrhoids and required surgery, the patient's temperature became 39.1 degrees.Antipyretic supplement fluid therapy was given.
 
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Brand Name
SURGIPRO
Common Device Name
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
MDR Report Key8976559
Report Number1219930-2019-05082
Device Sequence Number221340
Product Code FTL
UDI-Device Identifier10884521101319
UDI-Public10884521101319
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K982575
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date02/28/2023
Device Model NumberSMPL-01
Device Catalogue NumberSMPL-01
Device Lot NumberA8B104X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/15/2019
Initial Report FDA Received Date09/09/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age72 YR
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