MAUDE Adverse Event Report: ETHICON INC. PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT; SURGICAL SEALANT

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

Patient Problems Wound Dehiscence (1154); Erythema (1840); Unspecified Infection (1930); Necrosis (1971); Scar Tissue (2060); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts to obtain the following information have been made with no response 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 caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products 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.Citation: orthopedics.2018; 41(2):e262-e267; doi: 10.3928/01477447-20180213-05.(b)(4).

Event Description

It was reported via a journal article: title: the effects of platelet-rich plasma and activated collagen on wound healing in primary total joint arthroplasty.Author/s: aldo bove,david c.Evans, ba; bruce g.Evans, md.Citation: orthopedics.2018; 41(2):e262-e267; doi: 10.3928/01477447-20180213-05.The objective of this (b)(6) study was to determine whether additives would improve wound outcomes and prevent postoperative complications in primary total knee and total hip surgeries.A total of 90 patients with osteoarthritis underwent elective primary total knee or total hip arthroplasty and were randomized into three groups: group 1 (n=30; n=10 male and n=20 female; average body mass index [bmi] of 28.2±6.7 kg/m^2) ¿ receiving platelet-rich plasma (prp) prior to wound closure; group 2 (n=30; n=13 male and n=17 female; average bmi of 32±8.1 kg/m^2) ¿ receiving activated collagen prior to wound closure; and group 3 (n=30; n=13 male and n=17 female; average bmi of 28.3±5.7 kg/m^2) ¿ acted as control (without additive).In all patients, dermabond prineo skin closure system (ethicon) was used in skin closure.Postoperatively, overall outcomes included erythema (n=21 at 2 weeks; n=4 at 6 weeks), induration (n=10 at 2 weeks; n=2 at 6 weeks), swelling (n=39 at 2 weeks; n=8 at 6 weeks), wound separation (n=2 at 2 weeks; n=5 at 6 weeks) which required irrigation and closure in one patient, tissue necrosis (n=8 at 2 weeks; n=3 at 6 weeks); elevated scar (n=5 at 6 weeks); and superficial wound infection (n=12 at 6 weeks) cleared with antibiotics in all and one patient required irrigation and debridement with closure over drains.On the basis of this study, these additives are not recommended for routine primary joint arthroplasty; however, the data suggest possible benefits for high-risk patients and those for whom blood loss may be an issue.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9198292
• MDR Text Key: 162969788
• Report Number: 2210968-2019-88729
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/20/2019
• Initial Date FDA Received: 10/16/2019
• 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