MAUDE Adverse Event Report: ETHICON INC. PROLENE* POLYPROPYLENE MESH; MESH, SURGICAL, POLYMERIC

Catalog Number PMH

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

Patient Problems Unspecified Infection (1930); Inflammation (1932); Pain (1994); Cramp(s) (2193)

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.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.Questions for patient: if in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide your surgeon¿s name, contact information and sign release of medical information form attached.Questions for doctor: the patient demographic info: age, gender, weight, bmi at the time of index procedure date and name of initial surgical procedure.The diagnosis and indication for the initial surgical procedure? what were current symptoms following the index surgical procedure? onset date? what are the patient comorbidities/concomitant medications? if applicable, will product be returned, return date, tracking information.What is physician¿s opinion as to the etiology of or contributing factors to this event what is the patient's current status? were any concomitant procedures performed? onset date/time of the pain from surgery.Location and character of the pain? is there any specific activity that precipitated the pain or eased the pain? what medical intervention was given for the pain management? results? if reoperation was performed please provide date and surgical findings was the device removed? if so, please date and details of the re-operation.

Event Description

It was reported that a patient underwent an incisional hernia repair surgery on (b)(6) 2015 and a mesh was implanted.It was reported that the patient became critically ill within 12 to 24 hours after surgery.It was also reported that it was resulting in 2 pneumonia's partial lung collapses and several fractured ribs which is 5 currently.It was reported that patient had flu like symptoms all the time spasms and cramping like labour contractions at the four anchor points.It was reported that it would last from half an hour to hours spasms then let¿s go after 30 to a couple of minutes.It was reported that the only thing is apply pressure to the areas affected the are hard to touch and breathe like in labour and the patient had 4 labours.As reported by the patient depending on severity the area that cramps are painful to touch and hit to touch with redness and inflammation for up to days for the most one anchor point is always tender to touch.The patient considered suicide in 2016.The patient reported that she does not have pain relief.The patient reported that she has spasms scar tissue builds up making them more painful and a potentially damaging and stretching.All these issue the patient had over 4 years.It was reported that the patient has been on antibiotics for several month.It was reported that when the patient is off antibiotics she is unwell with infections around the mesh area temperature flu like symptoms and aching in every joint.It was also reported by the patient that the mesh is killing her.

• 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.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo 00754
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9205245
• MDR Text Key: 162854862
• Report Number: 2210968-2019-88665
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031049017
• UDI-Public: 10705031049017
• Combination Product (y/n): N
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: PMH
• Device Lot Number: DER836
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention