MAUDE Adverse Event Report: ETHICON INC. MALLA PROLENE SMALL 6CM X 11CM; MESH, SURGICAL, POLYMERIC

Catalog Number PMS3

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

Patient Problems Erythema (1840); Unspecified Infection (1930); Inflammation (1932); Swelling (2091)

Event Date 03/05/2019

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.It was reported that the wound was changed by wound drainage and anti-inflammatory treatment.The wound healed well.Did the patient experience drainage at the wound site or was a drain placed? if a drain was placed, was it placed post-operative? if a drain was placed tell us did the patient have to return to the or for drain placement or was it placed at the patient's bedside? the anti-inflammatory provide to patient: provide name of medication (anti-inflammatory) provided? was this medication a routine scheduled dose or was it a as needed medication i.E.Prn medication? what does the surgeon feel the etiology of the post op inflammation, redness, swelling and small amount of exudate was.Were the symptoms a result of the mesh, were the symptoms an expected outcome after a hernia repair? provide etiology? confirm patient's symptoms healed with out sequela? it was mentioned that the stitches were removed 12 days after the operation and the wound healed.Is there any significance such as was the suture prematurely removed? (provide the following: ) was there a product issue with the sutures? if yes provide the issue with the suture? if yes provide product code and lot number?.

Event Description

It was reported that a patient underwent a tension free hernia repair of right direct hernia on (b)(6) 2019 and the mesh was implanted.It was reported that there was post op inflammation.It was reported that on (b)(6) there was red and swollen around the wound, with a small amount of exudate.It was reported that the wound was changed by wound drainage and anti-inflammatory treatment.The wound healed well.The stitches were removed 12 days after the operation, and the wound healed.

Manufacturer Narrative

Product complaint #: (b)(4).Additional information was requested and the following was obtained: patient symptoms manifestations (location, severity, appearance, systemic or local reaction): unknown.Date - time of onset of infection from the surgical procedure? unknown.Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? unknown.Did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? unknown.Were cultures performed? results? unknown.What medical intervention was performed? results? the wound was changed by wound drainage and anti-inflammatory treatment.The wound healed well.

Manufacturer Narrative

Product complaint # (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Additional information was requested and the following was obtained: 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.It was reported that the wound was changed by wound drainage and anti-inflammatory treatment.The wound healed well.Did the patient experience drainage at the wound site or was a drain placed? if a drain was placed, was it placed post-operative? yes.If a drain was placed tell us did the patient have to return to the or for drain placement or was it placed at the patient's bedside? unk.The anti-inflammatory provide to patient: provide name of medication (anti-inflammatory) provided? unk.Was this medication a routine scheduled dose or was it a as needed medication i.E.Prn medication? unk.What does the surgeon feel the etiology of the post op inflammation, redness, swelling and small amount of exudate was.Infection which may be caused by product.Were the symptoms a result of the mesh, were the symptoms an expected outcome after a hernia repair? provide etiology? unk.Confirm patient's symptoms healed with out sequela? unk.It was mentioned that the stitches were removed 12 days after the operation and the wound healed.Is there any significance such as was the suture prematurely removed, did the suture perform in an unexpected manner.If yes provide the following: this provide the following: unk.Was there a product issue with the sutures? if yes provide the issue with the suture? if yes provide product code and lot number? 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.Patient symptoms manifestations (location, severity, appearance, systemic or local reaction) date - time of onset of infection 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? what medical intervention was performed? results?.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 5/18/2021.Additional information: h6.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.Product complaint # (b)(4).Date sent to the fda: 5/18/2021.Corrected information: d3, g1.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: MALLA PROLENE SMALL 6CM X 11CM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876 0151
• MDR Report Key: 8881720
• MDR Text Key: 153939991
• Report Number: 2210968-2019-85394
• 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: foreign,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PMS3
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR