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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.
 
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Brand NameMESH - SURGIPRO¿
Type of DeviceMESH, 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
Device Expiration Date12/31/2009
Device Model NumberSPM-35-W
Device Catalogue NumberSPM-35-W
Device Lot NumberA4M154
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/12/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/19/2019 Patient Sequence Number: 1
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