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 Unspecified Infection (1930); Seroma (2069)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.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.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? citation: pleura and peritoneum.2018; 1, special suppl; sa6¿sa463.Doi: https://doi.Org/10.1515/pap-2018-7016.(b)(4).

Event Description

It was reported via a journal article "title: bundled care to reduce surgical site infections after cytoreductive surgery and hipec".Authors: e.Poli, m.Millis, s.Sherman, f.Dahdaleh, a.Kamm, k.Turaga.Citation: pleura and peritoneum.2018; 1, special suppl; sa6¿sa463.Doi: https://doi.Org/10.1515/pap-2018-7016.Cytoreductive surgery (crs) and hyperthermic intraperitoneal chemotherapy (hipec) has been reported to have a high incidence (16%) of superficial and deep surgical site infections (ssi).The authors implemented an ssi bundle after inception of a regional therapies program in 2016.A total of 51 patients (mean age: 57.3 years) were included in the study.During the surgical procedure, wound closure was augmented with the dermabond prineo system (ethicon).Reported complications included suspected infection (n-4) which required 2 doses of antibiotics and superficial surgical site infection and seroma (n-1) which required 2 doses of antibiotics.Bundled care and systematic practices established at the inception of a regional therapies program at a large tertiary university hospital resulted in a low rate of surgical site infections.Translation of ssi reduction bundles from other surgical procedures appears feasible in patients undergoing crs and hipec.

• 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 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8994113
• MDR Text Key: 158880224
• Report Number: 2210968-2019-87007
• 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: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• 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: 08/15/2019
• 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