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 No Code Available (3191)

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: the knee capsule is closed with stratafix.The leg is at approximately 45 degree angle for suture and prineo application.Knees are covered with ace bandage post op.Fluid filled blisters are seen only at the distal end of the prineo.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.Please provide photos.Please provide additional event description for each patient.Initial procedure date.What date did the reaction occur post op? how was the reaction treated (product removed; reoperation; reclosure; prescription steroids; antibiotics prescribed)? if so, please clarify.Do you have the product code and lot number involved.What is the physicians opinion of the contributing factors to the blisters / reaction? is the product or representative sample (product from the same lot number) available for evaluation? patient demographics: initials / id; age or date of birth; bmi ; gender.Any update to patient current condition.

Event Description

Rrt conference call was held on (b)(6) with the sales rep to discuss recent prineo issues at (b)(6).The surgeon has been using prineo for about 18 months.Knee capsule is closed with stratafix.Leg is at approximately 45 degree angle for suture and prineo application.Knees are covered with ace bandage post op.Fluid filled blisters are seen only at the distal end of the prineo22.Doctor has drained these blisters and has prescribed antibiotics.Photos may be available.Rep will follow up with the surgeon to see if he will share photos.Patients have all fully recovered.Surgeon has said he has not changed anything in his normal routine.Rep is going to follow up with the surgeon to see if he will participate in a conference call with the cross functional rrt.

• 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; road 183, km. 8.3; san lorenzo PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7993734
• MDR Text Key: 124660916
• Report Number: 2210968-2018-76700
• 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: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• 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: 10/02/2018
• 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