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

Catalog Number PROMESHUNK

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

Patient Problems Erythema (1840); Unspecified Infection (1930); Pain (1994); Local Reaction (2035)

Event Date 07/04/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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: weight, bmi at the time of index procedure were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? were cultures performed? results? product code and lot #.Does the surgeon believe that the ethicon product (prolene mesh) involved caused and/or contributed to the post-operative complications described? does the surgeon believe there was any deficiency with the ethicon product involved? what is the patient's current status? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that a patient underwent an eventrorraphy procedure on (b)(6) 2020 and the mesh was implanted.It was reported that on (b)(6) 2020, the patient reported feeling well, with controlled pain, no fever, no emesis, satisfactory evolution.It was also reported that on (b)(6) 2020, the patient indicated that she had pain after surgical intervention associated with heat, redness and erythema, the day before she removed the drain.It was also reported that the patient had new paraclinics performed with pcr 22.26, hb: 10.4, platelets: 516000.It was reported that antibiotic treatment was started with cefazolin 2 g / 6 hours, tramadol 50 mg / 8 h, dipyrone 1 g / 8 h.It was reported that on (b)(6) 2020 the patient continued with the same management.It was reported that a review by a surgeon on (b)(6) 2020 indicated iso, with improvement in pain and heat, and collection was discarded.It was reported that enoxaparin 40 mg / sc / day was added.It was also reported that on (b)(6) 2020 a review by a surgeon indicated no peritoneal irritation, surgical wound in good condition, no secretions or bleeding.It was reported that with symptomatic and clinical improvement patient was given recommendations, warning signs, order of oral antibiotic, discharge and control appointment.(cephalexin 500 mg / 6 hours for 5 days).

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 12/29/2020.Additional information was requested and the following was obtained: - the patient demographic info: weight, bmi at the time of index procedure: weight: 60 kg, imc: 26.7.- were there any pre-existing signs/symptoms of active infection prior to this surgical procedure there were no signs / symptoms of infection prior to surgery.- were cultures performed? results? no cultures were performed.Product code and lot # : don¿t have this information.- does the surgeon believe that the ethicon product (prolene mesh) involved caused and/or contributed to the post-operative complications described? he doesn¿t - does the surgeon believe there was any deficiency with the ethicon product involved? he doesn¿t.- what is the patient's current status? the patient is in good health, has not presented hospital readmission.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.

• Brand Name: PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10933492
• MDR Text Key: 219310077
• Report Number: 2210968-2020-09495
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PROMESHUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/28/2020
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 60