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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 PMH
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Erosion (1750); Itching Sensation (1943); Pain (1994); Swelling (2091); Ambulation Difficulties (2544); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4). To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.
 
Event Description
It was reported that the patient underwent a bilateral inguinal hernia repair procedure in (b)(6) and mesh was implanted. The patient experienced pain, itching and limited mobility and therefore underwent two additional surgical procedures on the left side. In the second surgery, a limited probe was made and protacs were removed that had been placed in nerves. It was believed that another surgery might be needed to dissect the nerve and probe further. In the third surgery, the mesh had migrated to the upper left quadrant of the abdomen and more protacs were found in nerves and removed. An attempt was made to remove the mesh and damage to the area was becoming a problem, so that was abandoned and another mesh was placed. Meanwhile a nerve was dissected. Following the third procedure, the patient experienced protrusions, severe pain, mobility issues and swelling.
 
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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)
UNKNOWN
unknown
x
Manufacturer Contact
darlene kyle
route 22 west po box 151
somerville, NJ 08876
9082182792
MDR Report Key6486949
MDR Text Key72605398
Report Number2210968-2017-31627
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 03/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPMH
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/27/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 04/12/2017 Patient Sequence Number: 1
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