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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 SPMM-149
Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Tissue Damage (2104); Prolapse (2475); No Code Available (3191)
Event Date 09/12/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, post-operative a laparoscopic hysteropexy/ y/ mesh placement for pelvic organ prolapse, the mesh eroded. The patient attended with pain and recurrence of pelvic organ prolapse. The patient requested to remove the mesh. Laparoscopic assisted removal of mesh and subsequent vaginal hysterectomy and anterior colporrhaphy was done to resolve the issue. An unanticipated tissue loss and tissue damage resulted from this problem. The surgical procedure was extended for more than 30 minutes.

 
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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
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key8042240
MDR Text Key126260475
Report Number1219930-2018-05875
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK915526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 11/06/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/06/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/18/2014
Device MODEL NumberSPMM-149
Device Catalogue NumberSPMM-149
Device LOT NumberA5H0642WX
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured08/15/2015
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: 11/06/2018 Patient Sequence Number: 1
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