MAUDE Adverse Event Report: ETHICON INC. PVP MEDIUM 6.4CM X 6.4CM; MESH, SURGICAL, POLYMERIC

Model Number PVPM

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930)

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.Attempts are being made to retrieve the device.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.The patient demographic info: age, gender, weight, bmi at the time of index procedure clarify patient symptoms regarding the allergic reaction (location, severity, appearance, systemic or local reaction) date - time of onset of infection/allergic reaction from the surgical procedure? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? were cultures performed? results? was medical intervention required to treat the patient condition? results does the patient have known allergic history to medical device, food or medications? was there any allergy testing performed? if yes, results? what is physician¿s opinion as to the etiology of or contributing factors to this event if applicable, will product be returned, return date, tracking information what is the patient's current status?.

Event Description

It was reported that a patient underwent an umbilical hernia repair procedure on (b)(6) 2020 and the mesh was implanted.It was reported that after a few days infection and allergic reaction occurred.It was reported that since the wound fluid does not reduce, product might have to be explanted.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 12/11/2020.Additional information was requested and the following was obtained: the patient demographic info: age, gender, weight, bmi at the time of index procedure age 67 years, m, weight not known but normally built, bmi normal clarify patient symptoms regarding the allergic reaction (location, severity, appearance, systemic or local reaction) first there was a superficial wound infection around navel, then progressive circular reddening developed around navel (approx.10 cm diameter), and finally an abdominal wall phlegomone (approx.20x20 cm around navel) which led to the exploration of the mesh.Date - time of onset of infection/allergic reaction from the surgical procedure? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? preop normal skin conditions on the navel.Did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? intraop.Singleshot antibiotic, post-op long-term antibiosis po after antibiogram were cultures performed? results? multiple smears: 1.Abundant growth of prevotella b u c c a l l i s; 2.Fusobacterium nucleatum, prevotella buccae and anaerococcus spp.(peptostreptococci); 3.Parvimonas micra (peptostreptococci) was medical intervention required to treat the patient condition? results yes, wound spreading and wound irrigation, net explantation, vac.Vb.And secondary seam does the patient have known allergic history to medical device, food or medications? unknown.Was there any allergy testing performed? if yes, results? no.What is physician¿s opinion as to the etiology of or contributing factors to this event at first it was a question of a wound infection, this could not be controlled with the usual measures (wound spreading, wound rinsing, antibiosis).An allergic circular skin reddening around the navel was noticeable throughout the outpatient postoperative course.The only risk factor found was diabetes.If applicable, will product be returned, return date, tracking information? what is the patient's current status? released from hospital with stable wound conditions, skin consultation during the hospital treatment: primarily atop eczema with sebostasis and pruritus this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 1/04/2020.Additional b5 narrative: it was reported that a patient underwent an umbilical hernia repair procedure on (b)(6) 2020 and the mesh was implanted.It was reported that after a few days infection and allergic reaction occurred.It was reported that since the wound fluid does not reduce.It was reported that explantation was performed in different hospital than original surgery.Product complaint # (b)(4).Date sent to the fda: 1/04/2020.Corrected information: h6.

• Brand Name: PVP MEDIUM 6.4CM X 6.4CM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10806258
• MDR Text Key: 215489106
• Report Number: 2210968-2020-08820
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031132405
• UDI-Public: 10705031132405
• Combination Product (y/n): N
• PMA/PMN Number: K061533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: PVPM
• Device Catalogue Number: PVPM
• Device Lot Number: PCBBRZB0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention