MAUDE Adverse Event Report: ETHICON INC. DERMABOND UNKNOWN PRODUCT; ADHESIVE, TOPICAL SKIN

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

Patient Problem Wound Dehiscence (1154)

Event Date 09/01/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information: additional information has been requested however not 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.Does the surgeon believe that any of the ethicon products involved, caused and/or contributed to the post-operative complications described in the article? prolene suture (0-prolene suture), monocryl suture [monocryl suture (3-0 and 4-0), vicryl suture (2-0 vicryl suture): - wound dehiscence /treatment: not reported - abdominal hematoma /treatment: not reported - abdominal seroma /treatment: not reported dermaunk (dermabond unknown surgical skin adhesive): - wound dehiscence/treatment: not reported.Does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Which specific ethicon products have been used during the procedures (product code, lot number)? patient demographics? 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: plastic and reconstructive surgery (september 2021); 148:357e-364e.Doi: 10.1097/prs.0000000000008297.Note: events reported on: mw# 2210968-2023-02666, mw# 2210968-2023-02663, mw# 2210968-2023-02664, mw# 2210968-2023-02665.

Event Description

It was reported via journal article: title: the influence of closing the abdominal donor-site superficial fascial system in deep inferior epigastric perforator flap breast reconstruction this retrospective study aims to compare wound dehiscence and other donor-site complications and outcomes between the groups of patients who did and did not have abdominal superficial fascial system closure.A total of 103 female patients who underwent diep flap breast reconstructions performed between 2017 and 2019 were included in the study.Among these patients, 66 underwent donor-site closure with reapproximation of the superficial fascial system (superficial fascial system closure group) and 37 did not (no¿superficial fascial system closure group).The mean age and bmi were 51 ± 10.6 years and 51 ± 10.20 years, and 29 ± 5.51 kg/m2 and 28 ± 5.18 kg/m2, respectively.After flap harvest, the rectus fascia defect was closed with a buried 0 prolene suture (ethicon, inc., somerville, n.J.) in an interrupted figure-of-eight fashion.Two 15-french round blake drains (ethicon) were then placed.All drains were secured with 3-0 nylon sutures and a biopatch (ethicon).Reapproximation of the superficial fascial system layer in the superficial fascial system closure group was accomplished with simple interrupted 2-0 vicryl sutures (ethicon).Progressive-tension sutures were not used.In the no¿superficial fascial system closure group, this step was not completed.Further closure was accomplished in a standardized manner with buried interrupted deep dermal 3-0 monocryl sutures (ethicon).Approximately 1 cm of space was left between deep dermal sutures to restrict the amount of foreign material (sutures) left in the tissue.The skin was closed with a 4-0 running monocryl subcuticular suture.The position of the umbilicus was then excised on the abdominal wall and the umbilical stalk was delivered.The umbilicus was then inset with 4-0 monocryl deep dermal sutures.The incision was then covered with dermabond surgical skin adhesive (ethicon) and the patients were placed in an elastic abdominal binder.The mean follow-up was 16 months for the superficial fascial system closure group and 8.1 months for the no¿superficial fascial system group.Reported complications include: in the superficial fascial system closure group were wound dehiscence (n=12), abdominal hematoma (n=1), and abdominal seroma (n=4).In the no¿superficial fascial system closure group were wound dehiscence (n=3) and abdominal seroma (n=3).In conclusion, omission of superficial fascial system closure resulted in no difference in wound dehiscence or fat necrosis rates and aesthetic appearance of the abdominal scar and contour.

• Brand Name: DERMABOND UNKNOWN PRODUCT
• Type of Device: ADHESIVE, TOPICAL SKIN
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16728479
• MDR Text Key: 313188838
• Report Number: 2210968-2023-02663
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• 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?: Yes
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 0-PROLENE SUTURE; 15-FRENCH ROUND BLAKE DRAIN; 2-0 VICRYL SUTURE; 3-0 NYLON SUTURE; 3¿0 MONOCRYL SUTURE; 4-0 MONOCRYL SUTURE; BIOPATCH; DERMABOND SURGICAL SKIN ADHESIVE
• Patient Outcome(s): Other
• Patient Sex: Female