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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROCEED*SURG MESH/MULTI LYR; MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROCEED*SURG MESH/MULTI LYR; MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PCDG1
Device Problem Material Separation (1562)
Patient Problems Adhesion(s) (1695); Pain (1994); Hernia (2240); Not Applicable (3189)
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.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
 
Event Description
It was reported that the patient underwent a ventral hernia repair procedure on (b)(6) 2017 and mesh was implanted.Following the procedure, the patient experienced higher than normal pain.An exploratory laparotomy was performed on (b)(6) 2017.The surgeon found that the bowel adhered to the entirety of the mesh.The bowel was pulled which peeled the orc off of the mesh while still being stuck to the bowel.A new like device was placed over the old mesh and tacked down to complete the procedure.It was reported that a large number of tacks were used during each procedure.No device will be returned.
 
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Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville 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 08876-0151
9082182792
MDR Report Key7207240
MDR Text Key97802863
Report Number2210968-2018-70356
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K060713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Health Professional
Type of Report Initial
Report Date 12/20/2017
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 NumberPCDG1
Device Lot NumberLGG273
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/20/2017
Initial Date FDA Received01/19/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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