MAUDE Adverse Event Report: ETHICON INC. BLAKE DRAIN UNKNOWN PRODUCT; CATHETER, IRRIGATION

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

Patient Problems Cellulitis (1768); Hematoma (1884); Necrosis (1971); Seroma (2069)

Event Date 06/20/2020

Event Type  Injury  

Event Description

Title: alloderm and cortiva have similar perioperative wound complications in abdominal wall reconstruction.A retrospective chart review was performed to compare perioperative wound complications (up to 120 d postoperatively) between patients who underwent awr with the human noncrosslinked adms alloderm or cortiva from january 2012 to march 2020.Surgical technique uniformly consisted of open component separation, onlay implantation of adm, and progressive tension suture fixation of adm.There were slight variations in operative technique in terms of component separation release maneuvers from case to case.However, all patients received on lay adm with either alloderm or cortiva.A full description of the operative technique is described in a previous study published by the senior author.Briefly, an open approach is used, and skin flaps are elevated to expose the anterior abdominal wall.The edges of the hernia defect are defined and reapproximated with 0 vicryl (ethicon) simple interrupted sutures.An anterior component separation is then performed by releasing the external obliques bilaterally 1 cm lateral to the linea semilunares.The rectus muscles are then advanced to the midline to recreate myofascial continuity over the reapproximated hernia defect.The rectus muscles are inset with 0 vicryl simple interrupted sutures and reinforced with a, 0 looped nylon (ethicon) continuous running suture from the xiphoid process to the pubis.Adm is then placed over the area of the original hernia defect.It is secured in an onlay fashion with progressive tension interrupted mattress 0 vicryl sutures placed at 1-cm intervals starting from the midline, working out laterally in both directions.The adm overlaps the entire width of the anterior rectus sheath providing reinforcement of the native tissues.Subcutaneous 19-french blake (ethicon) drains are used routinely.Reported complications included wound necrosis, hematoma, seroma, cellulitis.In conclusion given the similar perioperative wound complication profiles, the more costeffective adm may be a consideration for use in awr.The fact that there were zero instances of adm explantation also supports the use of adm in these high-risk cases.

Manufacturer Narrative

(b)(4).Additional information was requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Does the surgeon believe that any of the ethicon products involved (vicryl suture, nylon suture, blake drain) caused and/or contributed to the post-operative complications described in the article: wound necrosis, hematoma, seroma, cellulitis? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure: vicryl suture, nylon suture, blake drain? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? what surgical or medical intervention has been performed? 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.Note: related events reported on mw# 2210968-2021-09973, mw# 2210968-2021-09974.Citation:journal of surgical research november 2 0 2 0 ( 2 5 5 ) 2 5 5e2 6 0.Https://doi.Org/10.1016/j.Jss.2020.05.060.

Manufacturer Narrative

Product complaint # (b)(4).Please see article attached.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, 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: BLAKE DRAIN UNKNOWN PRODUCT
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12662321
• MDR Text Key: 283623775
• Report Number: 2210968-2021-09975
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• PMA/PMN Number: CL I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• 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: 09/23/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention