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U.S. Department of Health and Human Services

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

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ETHICON INC. PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number SPMH
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Erosion (1750); Pain (1994); Urinary Frequency (2275); Hematuria (2558); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4) date sent to the fda: 01/06/2016. (b)(4).
 
Event Description
It was reported that the patient underwent a gynecological procedure on (b)(6) 2005, and a mesh was implanted. It was reported that following insertion the patient 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
 
Manufacturer Narrative
It was reported that the patient concurrently underwent transvaginal urethrolysis, suprapubic tube placement and cystoscopy. No additional information was provided.
 
Manufacturer Narrative
It was reported that following insertion the patient experienced dysuria, hematuria and urinary frequency. No additional information was provided.
 
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Brand NamePROLENE POLYPROPYLENE MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-PENDING DETERMINATION
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer Contact
kenneth clark
route 22 westp o box 151
somerville, NJ 08876
9082183547
MDR Report Key5348602
MDR Text Key35192134
Report Number2210968-2016-00246
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 08/31/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2010
Device Catalogue NumberSPMH
Device Lot NumberUCE669
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 Received08/31/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/25/2005
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: 01/06/2016 Patient Sequence Number: 1
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