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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); Migration or Expulsion of Device (1395); Material Deformation (2976); Material Integrity Problem (2978); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abscess (1690); Bacterial Infection (1735); Emotional Changes (1831); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Hernia (2240); Anxiety (2328); Distress (2329); Deformity/ Disfigurement (2360); Fluid Discharge (2686); Unspecified Tissue Injury (4559); Decreased Appetite (4569)
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 recurrence, mesh migrating, internal ring damage, nerve damage, pain, and suffering. Post-operative patient treatment included revision surgery.
 
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 recurrence, mesh migrating, internal ring damage, nerve damage, pain, and suffering. Post-operative patient treatment included revision surgery and mesh removal.
 
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Brand NameSURGIPRO
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
Manufacturer (Section G)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
Manufacturer Contact
tracy landers
5920 longbow drive
boulder, CO 80301
3035816943
MDR Report Key11286374
MDR Text Key230498607
Report Number9615742-2021-00329
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K915526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2008
Device Model NumberSPM-35
Device Catalogue NumberSPM-35
Device Lot NumberA3L392
Was Device Available for Evaluation? No
Date Manufacturer Received04/06/2022
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: 02/05/2021 Patient Sequence Number: 1
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