MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE; SURGICAL SEALANT

Model Number CLR222US

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

Patient Problems Unspecified Infection (1930); Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

Product complaint # pc (b)(4).Date sent to the fda: 9/28/2020.Additional information: from this august, the surgeon noted he changed the steroid, which is applied into the joint, to kenacort.When blood came out of the wound sometimes, affinity between kenacort included in the blood and the prineo might have been bad, and this might have caused the issue.The surgeon opined: there was causal relationship between the product and event.Attempts to obtain the following information have been made and the following was received.To date the device has not been received.If the further details are received at a later date a supplemental medwatch will be sent.¿ what is the procedure date? no further information is available.¿ what date did the reaction occur on ? 4-7 days after surgery.¿ what is the appearance and size of the reaction? no further information is available.¿ do you have any pictures of the reaction? no photos are available.¿ was there wound dehiscence reported? no.¿ please clarify ¿when blood came out of the wound¿.No further information is available.¿ were cultures performed? no further information is available.¿ was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.No further information is available.¿ what is the most current patient status? no further information is available.¿ was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? no further information is available.No further information will be provided.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported a patient underwent a total knee arthroplasty on an unknown date and topical skin adhesive with mesh was used.About 4- 7 days after the procedure, dermatitis occurred.Then, the mesh was removed, and the patient was discharged from the hospital.But 2 days later, deep infection was found.The lot number is unknown.Further details are not provided.No sample will be returned.Additional information has been requested.

Manufacturer Narrative

Product complaint #: (b)(4).Date sent to the fda: 10/7/2020.The following information has been requested and obtained.Attempts to obtain the device have been made.To date the device has not been received.If the further details are received at a later date a supplemental medwatch will be sent.Do you have any pictures of the reaction? no photos are available.Was there wound dehiscence reported? did blood came out of the wound? no wound dehiscence.Blood came out of the wound.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10592144
• MDR Text Key: 208723610
• Report Number: 2210968-2020-07364
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• Combination Product (y/n): N
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CLR222US
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention