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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 UNKNOWN SURGIPRO MESH
Device Problems Degraded (1153); Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Emotional Changes (1831); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Hernia (2240); Anxiety (2328); Distress (2329); Impaired Healing (2378); Hematuria (2558); Fluid Discharge (2686); Unspecified Tissue Injury (4559); Decreased Appetite (4569); 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 a laparoscopic therapeutic treatment of a left inguinal hernia. It was reported that after the implant, the patient experienced recurrence, adhesions, infection, mesh erosion, hematuria, fistula, abscess, mesh migration, damage to the bladder, and pain and suffering. Post-operative patient treatment included mesh removal surgery, and revision surgery.
 
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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 Key12112123
MDR Text Key260214645
Report Number9615742-2021-01651
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN SURGIPRO MESH
Device Catalogue NumberUNKNOWN SURGIPRO MESH
Device Lot NumberAOB254
Was Device Available for Evaluation? No
Date Manufacturer Received10/27/2021
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: 07/02/2021 Patient Sequence Number: 1
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