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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PROMESHUNK
Device Problems Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)
Patient Problems Erosion (1750); Unspecified Infection (1930); Pain (1994); Urinary Frequency (2275); Hematuria (2558); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Date sent to the fda: 07/31/2017 additional information: additional patient codes: (b)(4)- urinary problems, bowel problems, recurrence additional narrative: it was reported that following insertion the patient experienced infection, urinary problems, bowel problems, and recurrence.
 
Manufacturer Narrative
(b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further info 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 an undisclosed date and mesh was implanted. It was reported that she experienced undisclosed injuries. No additional information was provided.
 
Manufacturer Narrative
(b)(4). It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2011 and gynemesh/gynemesh ps 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
It was reported that following insertion the patient experienced urinary frequency and hematuria.
 
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Brand NamePROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
UNKNOWN
unknown
x NJ 08876 0151
Manufacturer Contact
darlene kyle
route 22 west po box 151
somerville, NJ 08876
9082182792
MDR Report Key5926383
MDR Text Key104928927
Report Number2210968-2016-12773
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 07/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPROMESHUNK
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/27/2017
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 Treatment Data
Date Received: 09/02/2016 Patient Sequence Number: 1
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