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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 SPM35
Device Problems Loss of or Failure to Bond (1068); Degraded (1153); Material Erosion (1214); Migration or Expulsion of Device (1395); Product Quality Problem (1506); Detachment of Device or Device Component (2907); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)
Patient Problems Erosion (1750); Emotional Changes (1831); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Scarring (2061); Increased Sensitivity (2065); Hernia (2240); Discomfort (2330); Injury (2348); Obstruction/Occlusion (2422); Fibrosis (3167); No Code Available (3191); Increased Sensitivity (4538); Nodule (4551); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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. After a procedure where this device was implanted, the patient experienced pain, bowel obstruction, and recurrence of hernia. Treatment included surgical revision and removal of the mesh.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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 inguinal hernia. After treatment, the patient experienced nerve damage, infected mesh, pain, bowel obstruction, recurrence, painful, tender, hard lump on right, extreme sensitivity and pain to right testicle and scrotum, scar tissue and mesh was noted as gnarled, knotted, hard, red, fibrotic, and dislocated with fragments of prolene suture. Post-operative patient treatment included surgical revision, removal surgery, and additional surgery.
 
Event Description
The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of an inguinal hernia. After treatment, the patient experienced surgical revision, removal surgery, pain, bowel obstruction, recurrence, painful, tender, hard lump on right, extreme sensitivity and pain to right testicle and scrotum, scar tissue and mesh was noted as gnarled, knotted, hard, red, fibrotic, and dislocated with fragments of prolene suture. Post-operative patient treatment included additional 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 an inguinal hernia. After treatment, the patient experienced defective device, mental and physical pain, injury, disability, loss of enjoyment of life, nerve damage, infected mesh, pain, bowel obstruction, recurrence, painful, tender, hard lump on right, extreme sensitivity and pain to right testicle and scrotum, scar tissue, mesh entrapped in nerves, wadded up mesh, mesh broke loose, and mesh was noted as gnarled, knotted, hard, red, fibrotic, and dislocated with fragments of prolene suture. Post-operative patient treatment included surgical revision, removal surgery, and additional surgery.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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 inguinal hernia. After treatment, the patient experienced nerve damage, pain, bowel obstruction, recurrence, painful, tender, hard lump on right, extreme sensitivity and pain to right testicle and scrotum, scar tissue and mesh was noted as gnarled, knotted, hard, red, fibrotic, and dislocated with fragments of prolene suture. Post-operative patient treatment included surgical revision, removal surgery, and additional 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 an inguinal hernia. After treatment, the patient experienced inflammation, scarification, mesh encapsulation, lack of adequate ingrowth, fibrosis, giant cell reaction, defective device, mental and physical pain, injury, disability, loss of enjoyment of life, nerve damage, infected mesh, pain, bowel obstruction, recurrence, painful, tender, hard lump on right, extreme sensitivity and pain to right testicle and scrotum, scar tissue, mesh entrapped in nerves, wadded up mesh, mesh broke loose, and mesh was noted as gnarled, knotted, hard, red, fibrotic, and dislocated with fragments of prolene suture. Post-operative patient treatment included surgical revision, removal surgery, and additional surgery.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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
tracy landers
5920 longbow drive
boulder, CO 80301
3035816943
MDR Report Key7735400
MDR Text Key115563452
Report Number1219930-2018-04195
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 Other,Consumer
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2010
Device Model NumberSPM35
Device Catalogue NumberSPM35
Device Lot NumberA5K303
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/22/2021
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: 07/31/2018 Patient Sequence Number: 1
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