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); Hematoma (1884); Inflammation (1932); Seroma (2069); Post Operative Wound Infection (2446)

Event Date 12/02/2020

Event Type  Injury  

Event Description

Title: comparison of peak plasmablade tm to conventional diathermy in abdominal-based free-flap breast reconstruction surgery¿a single-centre double-blinded randomised controlled trial.The aim of this study is to compare the ppb with the conventional diathermy for the raise of abdominal freeflaps in immediate and delayed breast reconstruction patients and compare outcomes, such as drain requirement, total drainage, inflammatory markers in drain fluid and complications, such as wound-healing problems and seroma formation.A single-centre, double-blinded, randomised controlled trial (rct) was conducted which included 108 abdominal based free-flap breast reconstruction patients who had their flap raise performed using either the ppb (n=56) or the conventional diathermy (n=52).At the end of the procedure, each patient received two abdominal 15 french blake drains(ethicon) connected to a low vacuum wound drainage system (85 kpa/neg, 100 mmhg).Drains were removed as per protocol when they produced =30 ml/24 h, with a maximum of 14 days.Reported complications included inflammation, abdominal drains, seroma with discomfort, abdominal wound infection, partial abdominal wound breakdown and abdominal hematoma.In conclusion the use of the ppb did not result in a significant reduction of drain requirement, total drain output or inflammatory cytokines but did reduce the size of seroma collections at the 2-week follow-up appointment.Therefore, the use of the ppb device could reduce early seroma formation after drain removal.

Manufacturer Narrative

(b)(4).Additional information has been requested however not received to date.If further details are received at a later date a supplemental medwatch will be sent.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon products involved: unknown blake drain caused and/or contributed to the post-operative complications (inflammation, abdominal drains, seroma with discomfort, abdominal wound infection, partial abdominal wound breakdown, abdominal hematoma) described in the article? does the surgeon believe there was any deficiency with the ethicon products: unknown blake drain used in these procedures? 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.Citation: journal of plastic, reconstructive & aesthetic surgery 74 (2021) 1731¿1742.Https://doi.Org/10.1016/j.Bjps.2020.12.007.

• 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.-INDIA; 251, sector-6, imt manesar; gurgaon 12205 0; IN 122050
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13172951
• MDR Text Key: 288515503
• Report Number: 2210968-2022-00104
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: CL I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• 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: 12/09/2021
• 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