MAUDE Adverse Event Report: ETHICON INC. PRINEO SKIN CLOSURE SYSTEM; SURGICAL SEALANT

Catalog Number CLR222US

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Wound Dehiscence (1154); Reaction (2414)

Event Date 12/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.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 describe any medical or surgical intervention provided to treat the blistering or the wound dehiscence? what was the angle of the knee during application? do you have any pictures of the reaction? size of dehiscence at central portion of incision? procedure date, location and incision size of product application? what prep was used prior to prineo use? please describe how the adhesive was applied on the tape? was the dermabond liquid adhesive placed to cover the entire length of the mesh? was incision re-prepped before closure? if so, with what? if so, was the prep allowed to dry? was a dressing placed over the incision? if so, what type of cover dressing used? date of reaction.How large of an area does the reaction cover? did the skin reaction extend beyond the borders of the tape.Was the product removed? was another method used to close the incision? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? is the patient hypersensitive to pressure sensitive adhesives? were any patch or sensitivity tests performed? lot number involved.What is the physicians opinion of the contributing factors to the reaction? what is the most current patient status? 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.Patient pre-existing medical conditions (ie.Allergies, history of reactions).For female patients ask if they were exposed to similar products, such as artificial nails.Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure?.

Event Description

It was reported that the patient underwent total knee arthroplasty procedure on an unknown date and topical skin adhesive was used.The patient returned to the office two weeks post-op with a blister and some wound dehiscence at the central portion of the incision that was closed with topical skin adhesive.Additional information has been requested.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM
• 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 PR; 982 road 183 km 8.3; san lorenzo PR 00754
• Manufacturer Contact: krystina laguna ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183043
• MDR Report Key: 6198031
• MDR Text Key: 63074230
• Report Number: 2210968-2016-15622
• Device Sequence Number: 1
• Product Code: OMD
• 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
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention