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

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.

• Type of Device: MESH, 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 Key: 8326290
• MDR Text Key: 135733280
• Report Number: 2210968-2019-78791
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K060713
• Number of Events Reported: 1
• 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 Received: 02/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 10/31/2019
• Device Catalogue Number: PCDN1
• Device Lot Number: LLG447
• 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 Received: 02/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2018
• 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