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 Problem Unspecified Infection (1930)

Event Date 06/01/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information was requested however no response has been received to date: please explain quantity involved 2? were there 2 patient events? initial procedure date.What prep was used prior to, during or after prineo use? was a dressing placed over the incision? if so, what type of cover dressing used? was the site cultured? if so, what bacteria were identified? what is the physicians opinion of the contributing factors to the infection? what is the most current patient status? how was the patient treated? what medical / surgical interventions were performed? did the patient have a pre-existing infection? patient pre-existing medical conditions (ie.History of infections).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported a patient underwent an double hip surgery on an unknown date in (b)(6) 2019 and topical skin adhesive was used.Two months after the surgery, the patient returned to the hospital with pain on an unknown date in (b)(6) 2019.It was suspected the patient had a surgical site infection, result of the water was in hip.The conclusion from the mri was that the infection was judged to be from outside to inside by patient's skin, and that there was no cause of surgical site infection in the surgery room.The conclusion by hospital is that adhesive is suspected to be the cause.Infection was treated after returning to hospital.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Sent to the fda: 08/12/2019.The following additional information was received: what is the physicians opinion of the contributing factors to the infection? the doctor said that there was no ssi factor in the operating room.The difference was the use of prineo, and the mesh was believed to have been a resource for surgical site infection.

• 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
• MDR Report Key: 8799972
• MDR Text Key: 151351804
• Report Number: 2210968-2019-84414
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• 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
• Date Manufacturer Received: 08/07/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR