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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN MESH NORTH HAVEN - SURGIPRO¿ MESH, SURGICAL, POLYMERIC

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COVIDIEN LP LLC NORTH HAVEN MESH NORTH HAVEN - SURGIPRO¿ MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number SPM-35-W
Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abscess (1690); Purulent Discharge (1812); Edema (1820); Emotional Changes (1831); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Internal Organ Perforation (1987); Pain (1994); Weakness (2145); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); Blood Loss (2597); Abdominal Distention (2601); 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
This information was received as a part of an extensive mesh litigation submission to medtronic. The fda was notified of this large complaint receipt. 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. It was reported that after the implant, the patient experienced pain, bleeding, bowel obstruction, infections, perforation, and recurrence. Post-operative patient treatment included revision surgery and recurrence repair.
 
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. It was reported that after the implant, the patient experienced pain, bleeding, bowel obstruction, infections, perforation, recurrence, inflamed tissue, friable tissue, exposed mesh, bulging, weakness, copious amounts of white pus, edematous, and abscess with multiple loculations and tracking. Post-operative patient treatment included revision surgery, incision and drainage of abscess, excision of infected mesh, and recurrence repair.
 
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 left inguinal hernia. It was reported that after the implant, the patient experienced pain, bleeding, bowel obstruction, infection, perforation, recurrence, inflamed tissue, friable tissue, exposed mesh, bulging, weakness, copious amounts of white pus, edematous, defective device, mental and physical pain, injury, disability, loss of enjoyment of life, and abscess with multiple loculations and tracking. Post-operative patient treatment included revision surgery, incision and drainage of abscess, excision of infected mesh, and recurrence repair.
 
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 resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. The patient underwent a open left inguinal hernia repair. He had revision surgery 1 months post-surgery. The patient experienced surgical revision, pain, bleeding, bowel obstruction, infections, perforation, recurrence.
 
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Brand NameMESH NORTH HAVEN - SURGIPRO¿
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, CT 80301
3035816943
MDR Report Key7176518
MDR Text Key174624823
Report Number1219930-2018-00247
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 Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 11/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSPM-35-W
Device Catalogue NumberSPM-35-W
Device Lot NumberAOE0716
Was Device Available for Evaluation? No
Date Manufacturer Received10/20/2021
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: 01/09/2018 Patient Sequence Number: 1
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