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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 Injury (2348); No Code Available (3191)
Date of Event 12/04/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter: occurred post-operatively following an open inguinal hernia repair.The device had a defect approximately 3-5cm after the incision.There was wound exudate which was infected and required dressing for more than one month.The patient status is alive, with injury.
 
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Brand Name
SURGIPRO
Common Device Name
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott ave
north haven CT 06473
MDR Report Key7162744
Report Number1219930-2018-00082
Device Sequence Number18850277
Product Code FTL
UDI-Device Identifier20884521101316
UDI-Public20884521101316
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K982575
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/03/2018
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 Date03/31/2022
Device Model NumberSMPL-01
Device Catalogue NumberSMPL-01
Device Lot NumberA7C0685X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/04/2017
Initial Report FDA Received Date01/03/2018
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 Hospitalization; Required Intervention;
Patient Age24 YR
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