MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM SKIN CLOSURE; SURGICAL SEALANT

Catalog Number CLR222US

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

Patient Problems Unspecified Infection (1930); Not Applicable (3189)

Event Date 02/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested and the following was obtained: how was the prineo adhesive applied on the mesh? saturated - entire mesh covered with one solid saturated coat what date did the infection occur on? doctor saw patient 20 days after and patient said it looked normal so doctor was not sure when the infection occurred.Was there any medical or surgical intervention performed? re-operation and then antibiotics.Can you identify the lot number of the product that was used? no.What is the most current patient status? hasn¿t seen the patient back post op since re-opening.Patient demographics: (b)(6), gender: f, smoker, non-compliant diabetic.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.Initial procedure date the diagnosis and indication for the index surgical procedure? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? location and size of infection? date of second procedure can you describe the infection site? any pictures? please describe what was done during the reoperation? please indicate any medical /surgical interventions performed was the site cultured? if so, what bacteria were identified? what in the physicians opinion are the causative factors for the patient infection? does the surgeon believe that the dermabond/prineo contributed to the patient event? was there any alleged dermabond / prineo deficiency noted prior/during or post operatively? update to patient current condition.

Event Description

It was reported that the patient underwent an abdominal hysterectomy procedure on (b)(6) 2018 and topical skin adhesive was used.The doctor saw the patient twenty days after the procedure and the patient looked normal.The patient developed an infection and the doctor was not sure when the infection occurred.The patient had a re-operation and then antibiotics.Additional information has been requested.

• Brand Name: DERMABOND PRINEO 22CM SKIN CLOSURE
• 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; 982 road 183 km 8.3; 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: 7349872
• MDR Text Key: 102787988
• Report Number: 2210968-2018-71515
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2018

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
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/23/2018
• Initial Date FDA Received: 03/19/2018
• 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
• Patient Outcome(s): Required Intervention