• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COVIDIEN LP LLC NORTH HAVEN SURGIPRO MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN SURGIPRO MESH
Device Problems Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Purulent Discharge (1812); Emotional Changes (1831); Hematoma (1884); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Ulcer (2274); Discomfort (2330); Impaired Healing (2378); Ascites (2596); Fluid Discharge (2686); Fibrosis (3167); Nodule (4551); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
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 a hernia. It was reported that after the implant, the patient experienced abscess, adhesions, inflammation, necrosis, right flank mass, infection, hematoma, groin pain, open draining wound, mesh migration, fibrosis, ulcer, swelling, purulent material, fluid loculations, gram-positive cocci pairs as well as yeast, and mesh detachment. Post-operative patient treatment included removal of mesh and incisional biopsy right hemi-pelvis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
Manufacturer Contact
tracy landers
5920 longbow drive
boulder,co, CT 80301
3035816943
MDR Report Key10844398
MDR Text Key216388207
Report Number1219930-2020-04906
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 Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 04/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2020
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 NumberA5C96
Was Device Available for Evaluation? No
Date Manufacturer Received04/13/2022
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: 11/16/2020 Patient Sequence Number: 1
-
-