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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 SPM-35
Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Patient Problems Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Unspecified Infection (1930); Ischemia (1942); Necrosis (1971); Staphylococcus Aureus (2058); Scarring (2061); Seroma (2069); Discharge (2225); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); Ascites (2596); Abdominal Distention (2601); Fibrosis (3167); No Code Available (3191)
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 umbilical hernia. It was reported that after implant, the patient experienced wound seroma, palpable masses above and below umbilicus filled with fluid, incarcerated recurrent hernia, small bowel obstruction, incarcerated segment of small bowel within hernia, involvement of the entire abdominal wall creating swiss cheese effect, defect measuring 20cmx20cm, recurrent incarcerated ventral hernia, a volvulizedsegment of jejunum was noted to be incarcerated, adhesions, infected mesh, small bowel mass, posterior mesh adherent to bowel, and multiple abscesses found in conjunction with the mesh. Post-operative treatment included incarcerated recurrent umbilical hernia repair with mesh, incarcerated recurrent ventral hernia repair with mesh, small bowel resection, anastomosis, lysis of adhesions, wound debridement of previous incision site, mesh revision surgery, removal of infected mesh, debridement of subcutaneous tissues and underlying skin,.
 
Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic. The fda was notified of this large complaint receipt. Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target. 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 umbilical hernia. It was reported that after implant, the patient experienced wound seroma, palpable masses above and below umbilicus filled with fluid, incarcerated recurrent hernia, small bowel obstruction, incarcerated segment of small bowel within hernia, involvement of the entire abdominal wall creating swiss cheese effect, defect measuring 20cmx20cm, recurrent incarcerated ventral hernia, a volvulizedsegment of jejunum was noted to be incarcerated, adhesions, infected mesh, small bowel mass, posterior mesh adherent to bowel, scar, and multiple abscesses found in conjunction with the mesh. Post-operative treatment included incarcerated recurrent umbilical hernia repair with mesh, incarcerated recurrent ventral hernia repair with mesh, small bowel resection, anastomosis, lysis of adhesions, wound debridement of previous incision site, mesh revision surgery, removal of infected mesh, debridement of subcutaneous tissues and underlying skin, creation of bilateral skin advancement flap, scar revision.
 
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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
MDR Report Key8499541
MDR Text Key141465453
Report Number1219930-2019-02179
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K915526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup
Report Date 12/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSPM-35
Device Catalogue NumberSPM-35
Device Lot NumberA8F503
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/10/2019 Patient Sequence Number: 1
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