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 Erythema (1840); Inflammation (1932); Irritation (1941); No Code Available (3191)

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.Current patient status.When was the perineo tape removed? was the tape removed by the surgeon? what treatments were required beyond removal of the tape? what type of medication? dose? when (date) administered? initial procedure date.What was the angle of the knee during application? what prep was used prior to perineo use? please describe how the adhesive was applied on the tape? was the mesh placed over the entire length of the incision? 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? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? is the patient hypersensitive to pressure sensitive adhesives? lot number involved.What is the physicians opinion of the contributing factors to the reaction?.

Event Description

It was reported that the patient underwent total knee procedure on an unknown date and topical skin adhesive was used.Four weeks after the procedure, the patient exhibited dermatitis, redness, blisters, irritation, and inflammation around the area where the product was applied.The surgeon used steri-strips to reinforce the incision.It was unknown if the topical skin adhesive had already been removed before the patient met with the surgeon or if the surgeon removed it before applying the steri-strips.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: 6266652
• MDR Text Key: 65386938
• Report Number: 2210968-2017-30315
• 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: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• 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: 01/06/2017
• 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