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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 UNK SURGIPRO MESH
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Patient Problems Abscess (1690); Adhesion(s) (1695); Cellulitis (1768); Purulent Discharge (1812); Unspecified Infection (1930); Inflammation (1932); Scar Tissue (2060); Ulceration (2116); Hernia (2240); Discomfort (2330); Injury (2348); Impaired Healing (2378); Ascites (2596); 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 an incisional hernia. It was reported that after implant, the patient experienced significant adhesions, chronic constipation, mesh sharply opened, adhesions stuck to the mesh, infected mesh, loop of small bowel, recurrence and open wound. Post-operative patient treatment included hernia repair with mesh and sutures, removal of mesh, small bowel resection as well as incision was irrigated and a wound vac was placed over the infected incision.

 
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Brand NameSURGIPRO
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 Key8529151
MDR Text Key142410754
Report Number1219930-2019-02475
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 12/17/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/18/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNK SURGIPRO MESH
Device Catalogue NumberUNK SURGIPRO MESH
Device LOT NumberA2G410
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/25/2019
Was Device Evaluated By Manufacturer? No Answer Provided
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: 04/18/2019 Patient Sequence Number: 1
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