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 Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The actual device batch number associated with this event is not known.Five possible batch numbers were reported as follows: batch mdh601 mfg.Date - 4/10/2018; exp.Date - 3/31/2020; batch mdh059 mfg.Date - 4/4/2018; exp.Date - 3/31/2020; batch mcq241 mfg.Date - 3/20/2018; exp.Date - 2/29/2020; batch mcq025 mfg.Date - 3/17/2018; exp.Date - 2/29/2020; batch mcj509.Mfg.Date - 3/12/2018; exp.Date - 2/29/2020.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Additional information was requested and the following was obtained: have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).No.What is the procedure name and initial procedure date? the procedure was tka and initial procedure date is unknown.What date did the reaction occur on? no information.Around 2 weeks after the surgery.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.Unknown.Can you identify the lot number of the product that was used? possible lot of clr222us was mdh601, mdh059, mcq241, mcq025 or mcj509.What is the most current patient status? unknown.Patient demographics: initials / id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i.E.Allergies, history of reactions) unknown.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 that patient underwent tka on unknown date and topical skin adhesive was used.Around 2 weeks after the procedure, the patient experienced infection.The doctor commented that treatment for infection was done, but detail is unknown.The surgeon opined there is no possibility that this event occurred due to the dermabond the current patient status is unknown.Additional information will be requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to fda: 11/30/2018.Additional information was requested and the following was obtained: please clarify the surgeon opinion that the infection was not related to the dermabond prineo.=>the surgeon commented that there is no possibility that this event occurred due to the dermabond.What is the physician¿s opinion of the contributing factors to the infection? =>there was a possibility that the suture was infected.Is the product or representative sample (product from the same lot number) available for evaluation? =>no sample will be returned.

• 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: 8045649
• MDR Text Key: 126364413
• Report Number: 2210968-2018-77010
• 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: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• 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: 11/19/2018
• Patient Sequence Number: 1
• Treatment: VICRYL PLUS SUTURE; VICRYL PLUS SUTURE
• Patient Outcome(s): Required Intervention