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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE* HERNIA SYSTEM; MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROLENE* HERNIA SYSTEM; MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PHSE
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Erosion (1750); Pain (1994); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
 
Event Description
It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2007 and mesh was implanted.It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2014 and ams-retroarc was implanted.It was reported that she experienced pain, erosion of her internal bodily tissue and other injuries following the procedure.It was reported that the patient has undergone multiple surgeries and revisionary procedures.No additional information was provided.
 
Manufacturer Narrative
(b)(4).It was reported that following insertion the patient experienced urinary problems and recurrence.It was reported that patient underwent mesh removal on (b)(6) 2014 by dr.(b)(6).
 
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Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
J-PAC
25 centre rd
somersworth NH 03878
Manufacturer Contact
krystina laguna
route 22 westp o box 151
somerville, NJ 08876
9082183043
MDR Report Key6154204
MDR Text Key61712426
Report Number2210968-2016-15254
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K984220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 01/25/2017
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 Catalogue NumberPHSE
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/27/2016
Initial Date FDA Received12/08/2016
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received01/02/2017
01/27/2017
Was Device Evaluated by Manufacturer? No
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 Age72 YR
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