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

Catalog Number PCDH1

Device Problem Peeled/Delaminated (1454)

Patient Problems Pain (1994); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.Did your husband have more than one hernia repair? if yes how many hernia repairs did he have (indicate a number)? where was each hernia for example ventral, inguinal, hiatal, umbilical? if more than 1 hernia was experienced was it a new hernia in a new location or did the initial hernia reoccur? if more than one surgery provide date of each hernia repair, if complete date is unknown provide the year of repair? in your recent contact you reported that your husband was in pain but refuses to have a 3rd surgery? is the pain a result of the initial hernia repair or was a second hernia repair performed then resulting in your husband experiencing pain? as a result of the pain did your husband obtain any medical or surgical intervention, it was noted that your husband is refusing to have a 3rd surgery.Please explain for example did you husband go to a doctor for his pain? if yes what did the doctor say? was treatment provided, medical or surgical? did the doctor recommend a third surgery? if yes why, was it for the pain? please clarify the product, the product code and the lot or serial number of the device you are reporting.Is it product code of pmh with serial number (b)(4) or is it proceed product pcdgh1 with lot ulg310, which number is correct or was more than one product used? do you have a copy of the post-operative report? 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 a patient underwent an open ventral hernia repair on an unknown date in 2005 and the mesh was implanted.It is was reported that the device completely delaminated during procedure, but the physician felt comfortable suturing through the device and continued with the implantation.It was also reported that when the mesh was being repaired in 2012 the patient was in pain but refused to have a third surgery.

Manufacturer Narrative

(b)(4).Corrected information: adverse event or product problem, outcomes attributed to adverse event, type of reportable event-this medwatch report is being voided.Based on received additional event information, there is no relation to the previous reported by sales rep event and product.All information regarding this event reported by patient¿s wife will be captured under medwatch report # 2210968-2019-84223.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8681270
• MDR Text Key: 147430291
• Report Number: 2210968-2019-82537
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K060713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 05/09/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2007
• Device Catalogue Number: PCDH1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/09/2019
• Initial Date FDA Received: 06/08/2019
• Supplement Dates Manufacturer Received: 06/18/2019
• Supplement Dates FDA Received: 07/12/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention