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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 Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Abscess (1690); Bacterial Infection (1735); Purulent Discharge (1812); Ecchymosis (1818); Emotional Changes (1831); Hematoma (1884); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Staphylococcus Aureus (2058); Scar Tissue (2060); Scarring (2061); Swelling (2091); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Fluid Discharge (2686); No Code Available (3191); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); 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 was reported that after a procedure where this device was implanted, the patient experienced surgical revision, infection.After treatment, the patient experienced 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 an epigastric hernia.It was reported that after implant, the patient experienced mental pain, pain/suffering, device defective, mesh failure, disability, impairment, loss of enjoyment of life, hematoma, exposed mesh, infection, inflammation, hernia recurrence, abscess, open wound, sinus drainage, staph aureus, ecchymosis, swelling, purulent material, granulation tissue, induration, scarring, sinus tract, and abdominal pain.Post-operative patient treatment included revision surgery, removal of graft material, incision and drainage of infection, old hematoma debrided, wound packed, antibiotics, and herniorrhaphy.
 
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 epigastric hernia.It was reported that after implant, the patient experienced infection, abscess, open wound, sinus drainage, staph aureus, ecchymosis, swelling, inflammation, purulent material, hematoma, granulation tissue, pain, induration, scarring, sinus tract, and recurrence.Post-operative patient treatment included revision surgery, removal of graft material, incision and drainage of infection, old hematoma debrided, wound packed, antibiotics, and herniorrhaphy.
 
Event Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an epigastric hernia.It was reported that after implant, the patient experienced infection, abscess, open wound, and recurrence.Post-operative patient treatment included revision surgery, removal of graft material, and herniorrhaphy.
 
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.
 
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Brand Name
SURGIPRO
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
MDR Report Key7648381
MDR Text Key112697420
Report Number1219930-2018-03489
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,Followup
Report Date 10/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSPM-35
Device Catalogue NumberSPM-35
Device Lot NumberA8A59
Was Device Available for Evaluation? No
Date Manufacturer Received09/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention; Disability;
Patient Weight81
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