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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN MESH - SURGIPRO¿ MESH, SURGICAL, POLYMERIC

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COVIDIEN LP LLC NORTH HAVEN MESH - SURGIPRO¿ MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number SPM-35-W
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Purulent Discharge (1812); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scarring (2061); Swelling (2091); Hernia (2240); Discomfort (2330); Injury (2348); Ascites (2596); Blood Loss (2597); Fibrosis (3167); No Code Available (3191); Constipation (3274)
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of a right-upper abdominal hernia. After implant, the patient experienced chronic pain, infected mesh, mesh failure, and an abdominal wall abscess. Post-operative treatment includes mesh revision on (b)(6) 2017.

 
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Brand NameMESH - SURGIPRO¿
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven 06473
Manufacturer (Section G)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven 06473
Manufacturer Contact
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key8174299
MDR Text Key130662451
Report Number1219930-2018-06700
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK915526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/11/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/18/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2017
Device MODEL NumberSPM-35-W
Device Catalogue NumberSPM-35-W
Device LOT NumberA2J0942X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/16/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/18/2018 Patient Sequence Number: 1
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