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); No Code Available (3191)

Event Date 08/21/2018

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: date that the dressing was removed: (b)(6).Location and incision size of product application? sternum, about 20cm.What prep was used prior to, during or after dermabond use? wiped down with water and dry the area.Was a dressing placed over the incision? if so, what type of cover dressing used? no dressing was placed over incision.Please indicate any additional medical or surgical intervention performed or planned? they had to remove dressing and clean the wound, the incision opened slightly they cleaned with hydrogen peroxide.Was the site cultured? if so, what bacteria were identified? unknown.Were any patch or sensitivity tests performed? unknown.Do you have the product code and lot number involved ? clr222us, unknown lot number what is the physicians opinion of the contributing factors to the reaction? unhappy and doesn¿t want to use dressing, possible contributing factors the pa suggested was due to big breasted women who¿s breast tissue covers the incision.However, she mentioned men have the same issues without the breast interfering.What is the most current patient status? recovering in the or and being monitored patient demographics: initials / id; age or date of birth; bmi.Unknown.Patient pre-existing medical conditions; unknown.

Event Description

It was reported that a patient underwent a cardiovascular procedure on an unknown date and topical skin adhesive was used.Two weeks post op, the pa removed a dressing from the patient in the office.The patient had pus and oozing from under the dressing as well as a foul smell, like it had been infected the dressing was removed, the wound opened slightly and was cleaned with hydrogen peroxide and air dried.The patient is currently recovering and being monitored.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; san lorenzo
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7856537
• MDR Text Key: 119644915
• Report Number: 2210968-2018-75711
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2018
• 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