MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO* PART. ABSORB. MESH; MESH, SURGICAL, POLYMERIC

Catalog Number UML1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Burning Sensation (2146); Hernia (2240); Unspecified Tissue Injury (4559)

Event Date 08/06/2014

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.  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 a hernia repair procedure on (b)(6) 2014 and the mesh was implanted.It was reported that when the patient first woke up from having the johnson & johnson ethicon ultra pro mesh implanted, the patient started to say something is very wrong, had horrific pain, burning, that no matter what it couldn't relieve, couldn't turn or bend without extreme pain, which has not changed to date.It was reported that the patient had previous hernia repairs that after every one within a very short time was back to a normal life, until this date, the patient was placed on huge doses of pain relief that is still used today.It was reported that the patient has seen many mental health doctors as well as pain clinics.It was also reported that the patient has undergone pain management courses to try to manage pain without further medication.It was also reported that the patient had emergency surgery resulting from a ruptured bowel, attached to mesh, very long complicated surgery where a colostomy bag was the result.It was reported that the pain has increased since surgery like a ball of barbed wire on fire.It was also reported that the patient now has re herniated in 2 places with a further kink in bowel, awaits further surgery, and has been seen by surgeons at 2 hospitals that have referred the patient to other surgeons as it is too complicated for them to fix.It was also reported that the patient is awaiting appointment with third surgeon.It was reported that the bowel has not worked in over 3 weeks, and now patient is back to nourishing fluid diet.It was also reported that the patient has ongoing pain and has not been able to work because of being bedridden due to the pain.No further information is available.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; p.o. box 1409; norderstedt D2284 1; GM D22841
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082182213
• MDR Report Key: 11105989
• MDR Text Key: 227570029
• Report Number: 2210968-2021-10426
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K033337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/09/2020

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 Expiration Date: 06/30/2016
• Device Catalogue Number: UML1
• Device Lot Number: DD8BPMS1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 01/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention