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 Unspecified Infection (1930); Impaired Healing (2378)

Event Date 02/26/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).(b)(4).Reported condition not returned.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 (infection, wound healing complication) described in the article? does the surgeon believe there was any deficiency with the ethicon products: unknown blake drain used in this procedure? 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, volume 74, pages 2565¿2572; doi: https://doi.Org/10.1016/j.Bjps.2021.02.005.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Title: reduction of seroma and improvement of quality of life after early drain removal in immediate breast reconstruction with tissue expander.Preliminary report from a randomized controlled study the goal of this randomized controlled trial was to compare early drain removal with output-based drain removal in patients who underwent mastectomy and immediate reconstruction with a tissue expander.Between september 2016 and march 2018, 49 patients who underwent mastectomy and breast reconstruction were included in the study.The patients were divided into 2 groups: group 1 (output-based; drains removed when < 30 ml/day); and group 2 (early-removal; at 3¿4 days postoperative).Group 1 consisted of 25 patients with a mean age of 53.4 +/-10.8 years and a mean bmi of 25.3 +/- 4.21 kg/m2.Group 2 consisted of 24 patients with a mean age of 52.6 +/- 18.9 years and a mean bmi of 26.2 +/- 5.41 kg/m2.All mastectomies and subpectoral pockets were performed using an ultrasonic scalpel focus ultracision harmonic scalpel (ethicon); a single drain was applied in the prepectoral area using the blake silicon flat drain 19g (ethicon), and the wounds were closed intradermally.The patients were implanted with a competitor¿s tissue expander.All patients were followed from the day before surgery until wound healing.Complications include infection (n=1) and complicated wound healing (n=2).In conclusion, the data suggest that it is clinically safe and preferable to remove drains early after breast cancer surgery.Better results were obtained for patients in the early-removal group, even when statistical significance was not obtained for each variable.Moreover, the potential improvement in qol for patients with breast cancer has a significant value.

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been requested and received.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.The cases discussed in our article have not previously been reported to ethicon.Does the surgeon believe that ethicon products involved: unknown blake drain caused and/or contributed to the post-operative complications (infection, wound healing complication) described in the article? we don't believe that the ethicon drains used caused and/or contributed to the postop complications.Does the surgeon believe there was any deficiency with the ethicon products: unknown blake drain used in this procedure? we believe there wasn't any deficiency with ethicon blake drain used in our procedures.We believe it is an excellent product.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.-INDIA; 251, sector-6, imt manesar; gurgaon 12205 0; IN 122050
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13172691
• MDR Text Key: 284622811
• Report Number: 2210968-2022-00100
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2022
• 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; Required Intervention