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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN MESH - SURGIPRO¿; MESH, SURGICAL, POLYMERIC
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COVIDIEN LP LLC NORTH HAVEN MESH - SURGIPRO¿; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number SPM-35-W
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Cyst(s) (1800); Pain (1994); Scarring (2061); Injury (2348); No Code Available (3191)
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.It was reported that after implant, the patient experienced dense adhesions.Post-operative treatment included multiple revision surgeries.
 
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.(b)(4).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.It was reported that after implant, the patient experienced dense adhesions and an adherent scar, pain, large right chest wall lesion and cyst.Post-operative treatment included multiple revision surgeries, exploration of left groin, partial removal of left inguinal hernia mesh with primary repair of left inguinal floor, and excision of mesh and cyst.
 
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.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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.It was reported that after implant, the patient experienced dense adhesions and an adherent scar.Post-operative treatment included multiple revision surgeries, exploration of left groin, partial removal of left inguinal hernia mesh with primary repair of left inguinal floor, and excision of mesh.
 
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Brand Name
MESH - SURGIPRO¿
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
MDR Report Key8714817
MDR Text Key148518530
Report Number1219930-2019-03593
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
Report Date 01/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2009
Device Model NumberSPM-35-W
Device Catalogue NumberSPM-35-W
Device Lot NumberA4M154
Was Device Available for Evaluation? No
Date Manufacturer Received06/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight98
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