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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-W
Device Problems Degraded (1153); Migration or Expulsion of Device (1395); Product Quality Problem (1506); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); Discharge (2225); Hernia (2240); Injury (2348)
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 hernia. It was reported that after implant, the patient experienced recurrent hernia due to failure of the mesh, migration of the mesh, mesh contraction, abscess, and infected mesh that led to chronic draining sinus/pain. Treatment provided for these conditions include surgical removal of the mesh.
 
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 a left inguinal hernia with perinephric fat in the scrotum. It was reported that after onlay implant, the patient experienced recurrent hernia due to failure of the mesh, migration of the mesh, mesh folded and rolled upon itself, mesh became corrugated and rolled up like a concrete-like mass, contraction, abscess, infected mesh that led to chronic draining sinus, two separate infected mesh with a gelatinous infected fluid surrounding them, and pain. Post-operative patient treatment include revision surgery, excision of mesh, meticulous hemostasis was done with the electrocautery, aspiration of exudate from wound and from around the mesh.
 
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. Concomitant medical products: in groin hernia non absorb plug taper sterile polyprop xl (2 plugs used). 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 left inguinal hernia with perinephric fat in the scrotum. It was reported that after implant, the patient experienced recurrent hernia due to failure of the mesh, migration of the mesh, mesh folded and rolled upon itself, mesh became corrugated and rolled up like a concrete-like mass, contraction, abscess, infected mesh that led to chronic draining sinus, two separate infected mesh with a gelatinous infectedfluid surrounding them, and pain. Post-operative patient treatment include revision surgery, excision of mesh, meticulous hemostasis was done with the electrocautery, aspiration of exudate from wound and from around the mesh. Concomitant devices were used: bard marlex 2x1. 6 in groin hernia non absorb plug taper sterile polyprop xl (2 plugs used).
 
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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 Key7972156
MDR Text Key123935989
Report Number1219930-2018-05528
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,other
Type of Report Initial,Followup,Followup
Report Date 01/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2018
Device Model NumberSPM-35-W
Device Catalogue NumberSPM-35-W
Device Lot NumberA3J0394X
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: 10/16/2018 Patient Sequence Number: 1
Treatment
BARD MARLEX 2X1.6
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