MAUDE Adverse Event Report: ETHICON INC. PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT; SUTURE, SURGICAL, ABSORBABLE

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

Patient Problems Wound Dehiscence (1154); Fever (1858); Nausea (1970); Pain (1994); Vomiting (2144); Fluid Discharge (2686); Not Applicable (3189)

Event Date 02/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.The single complaint was reported with multiple events.There are no additional details regarding the additional events.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.Does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative complications experienced by the two patients described in the article? does the surgeon believe there was any deficiency with the ethicon products (pds suture, prolene suture) used in this procedure? were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Citation: hernia (2019) 23:407¿409.Doi: https://doi.Org/10.1007/s10029-019-01910-2.Note: events reported via mw # 2210968-2020-08485.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 via journal article: "title: conservative treatment of infected mesh by use of gentamycin impregnated calcium sulphate antibiotic beads: a report of two cases".Author: c.M.Hoogerboord, m.Cwinn and s.F.Minor1.Citation: hernia (2019) 23:407¿409.Doi: https://doi.Org/10.1007/s10029-019-01910-2.This study presents conservative treatment of infected mesh by use of gentamycin impregnated calcium sulphate antibiotic beads.Two patients (male n=1 and female n=1).Were treated for mesh infection.A (b)(6)-year-old patient developed an anastomotic leak in her previous hepaticojejunostomy.The patient required an extensive adhesiolysis of intraabdominal adhesion.Ventralight mesh (non-ethicon) was placed over the fascial defect in the preperitoneal space and anchored to the diaphragm and abdominal wall muscle with a total of 8 2-0 pds suture (ethicon).The abdominal wall musculature was approximated over the mesh using no.1 pds (ethicon).Another patient, a (b)(6)-year-old male whose wound healing did not progress as expected with a midline incisional hernia of 7 cm width following a nissen fundoplication, had the option of debriding the exposed mesh and attempting to sterilize the remaining mesh with csab.The incorporated mesh was approximated with interrupted 2-0 prolene suture (ethicon).On post-operative day 14 of the female patient, she had fever (n=1), nausea (n=1), vomiting (n=1), worsening right hypochondrium pain(n=1), ct scan of her abdomen revealed a large collection anterior and posterior to the mesh in which approximately 400 ml of pus was drained (n=1), 2 cm dehiscence of the abdominal wall muscle (n=1) and cultures grew e coli sensitive to gentamicin and meropenem (n=1).She was treated with subsequent dressing change, csab were prepared with gentamicin and placed along the base of the wound and a layer of adaptic (non-ethicon) was used to cover the csab.The male patient reported an event of subsequent wound dehiscence at its inferior aspect (n=1).This was managed with npwt dressing and a 3-week course of cefazolin oral antibiotics.These 2 cases demonstrate the potential for csab to be used as part of a multimodality therapy in the salvage of prosthetic hernia meshes and represents a new tool for the surgeon in the management of this difficult clinical problem.

Manufacturer Narrative

Date sent to the fda: 12/08/2020.Corrected information: b3.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 inc, 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: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10762205
• MDR Text Key: 214108134
• Report Number: 2210968-2020-08486
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR