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 Wound Dehiscence (1154); Cellulitis (1768); Hematoma (1884); Unspecified Infection (1930); Seroma (2069)

Event Date 07/22/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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 any of the ethicon products involved: blake drain, nylon, vicryl, monocryl sutures, dermabond prineo, caused and/or contributed to the post-operative complications described in the article: cellulitis of the ipsilateral radiated breast, seroma formation, hematoma, dehiscence, infection? does the surgeon believe there was any deficiency with any of the ethicon products: blake drain, nylon, vicryl, monocryl sutures, dermabond prineo, used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.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.(b)(4).Device not returned.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Note: events reported on mw# 2210968-2021-12532, mw# 2210968-2021-12534, mw# 2210968-2021-12535, mw# 2210968-2021-12536.Citation cite: https://doi.Org/10.5999/aps.2020.00535, arch plast surg 2020;47:419-427.

Event Description

Title: blossom smart expander technology for tissue expander-based breast reconstruction facilitates shorter duration to full expansion: a pilot study this study aimed to evaluate an innovative self-filling, rate-controlled, pressure-responsive saline te system with an external sensing device.We investigated the feasibility of utilizing this technology to facilitate implant-based and flap with implant-based breast reconstruction in comparison to conventional tissue expansion.Fourteen patients were included in this study.Female volunteer patients meeting the inclusion criteria were enrolled from august 2018 to may 2020.In this prospective, single-center, single-surgeon pilot study, participants underwent either implant-based breast reconstruction or a combination of autologous flap and implant based breast reconstruction.The te external remote port fill tubing was exteriorized through a skin stab excision at the inferior lateral chest and secured to the skin with 3-0 nylon sutures (ethicon).A number 15 blake channel drain (ethicon) was placed in the subcutaneous pocket, brought out through a separate skin stab incision anterior to the te fill tubing, and secured to the skin with 3-0 nylon sutures.The wound edges were then reapproximated with interrupted 3-0 vicryl sutures(ethicon) in the deep dermis and the epidermis was approximated with a running 4-0 monocryl (ethicon) subcuticular stitch.All incisions were cleaned and dressed with the dermabond prineo skin closure system (ethicon inc., (b)(6), usa).Reported complications included: the patient reinserted a drain that had been pulled out and subsequently developed cellulitis of the ipsilateral radiated breast (n=1) requiring surgical intervention.Minor complication involved seroma formation following drain removal that resolved spontaneously (n=1), hematoma, dehiscence, infection resolved with oral antibiotics.In conclusion the reported average duration for conventional subcutaneous te expansion is 79.4 days, but this pilot study using the blossom system achieved an average expansion duration of less than 14 days in both groups.The blossom system may accommodate single-stage breast reconstruction.The overall complication rate of this study was 4.5%, which is promising compared to the reported complication rates of two-stage breast reconstruction with tes (20%¿45%).

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been requested and received to date.If further details are received at a later date a supplemental medwatch will be sent.Additional information received from the author: as indicated in paper, the infection involving the blake drain was due to patient re-inserting the drain after it has fallen out.It is not due to a defect/problem with the drain itself.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
• Manufacturer (Section G): DEGANIA SILICON LTD.-IND; 251, sector-6; imt manesar; gurgaon 12205 0; IN 122050
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12984356
• MDR Text Key: 286640472
• Report Number: 2210968-2021-12533
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CL I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention