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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 PCDN1
Device Problem Peeled/Delaminated (1454)
Patient Problem Not Applicable (3189)
Event Date 01/10/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot. If the device or further details are received at a later date a supplemental medwatch will be sent. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. The patient demographic info: gender, weight, bmi at the time of index procedure. Please describe the mesh fixation technique: device and technique? what technique was used to place the mesh into the abdomen? were there any surgical instruments used in the placement of the mesh that might have damaged the mesh? e. G. Graspers crimping the mesh fibers? what size trocar was used? was a second mesh used for the open procedure? -if no, was there a specific reason why a new mesh was not used? if a second mesh was used to complete the procedure, will the initial mesh used be returned? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? there was no sample received for analysis. Pictures were received for visual evaluation. Upon visual inspection of the pictures could be observed that, the anti-adhesion layer fell off partially. The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch. Due to the sample was not returned, we are unable to investigate further the issue and it could not be determined what may have caused the reported incident.
 
Event Description
It was reported that the patient underwent laparoscopic hernia repair on (b)(6) 2019 and mesh was used. During the procedure, most of the anti-adhesion layer fell off after mesh was fixed with sutures in laparoscopic repair of abdominal wall hernia. The rest of the anti-adhesion layer appeared as ¿empty drums¿ which affected normal use. The surgeon decided to change surgery into open procedure to remove the anti-adhesion layer and repaired it with the rest of the mesh layer. Additional information has been requested.
 
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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.-CORNELIA
655 ethicon circle
cornelia GA 30531
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8326290
MDR Text Key135733280
Report Number2210968-2019-78791
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K060713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2019
Device Catalogue NumberPCDN1
Device Lot NumberLLG447
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 Received02/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/23/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/11/2019 Patient Sequence Number: 1
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