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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. TOTAL PELVIC FLOOR REPAIR SYST; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

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ETHICON INC. TOTAL PELVIC FLOOR REPAIR SYST; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC Back to Search Results
Catalog Number PFRT01
Device Problem Other (for use when an appropriate device code cannot be identified) (2203)
Patient Problem Other (for use when an appropriate patient code cannot be identified) (2200)
Event Type  Injury  
Event Description
It was reported by an attorney that the patient underwent a gynecological procedure on an unknown date and an unknown mesh was implanted.It was reported that the patient experienced unspecified complications.No additional information has been provided.
 
Manufacturer Narrative
(b)(4).No conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.
 
Manufacturer Narrative
It was reported that the patient underwent a gynecological procedure on (b)(6) 2006 and prolift was implanted.No additional information was provided.In addition, a device history review has been inserted into the file.This review indicates that there was no quality concerns associated with the manufacturing process.
 
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Brand Name
TOTAL PELVIC FLOOR REPAIR SYST
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key4935944
MDR Text Key6010848
Report Number2210968-2015-09022
Device Sequence Number1
Product Code OTP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K013718
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/31/2007
Device Catalogue NumberPFRT01
Device Lot Number2904435
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/17/2015
Initial Date FDA Received07/23/2015
Supplement Dates Manufacturer Received12/08/2017
Supplement Dates FDA Received12/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/11/2006
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age65 YR
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