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); Itching Sensation (1943); Rash (2033); Reaction (2414); 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.Additional information was requested and the following was obtained: what is the procedure name? total hip.What is the procedure date? (b)(6).How was the device was used (what layer of tissue and how many layers applied)? one layer applied on skin.What was the location and incision size of prineo application? 10-12cm.What prep was used prior to prineo application? chloraprep at the beginning of the case.Was the prep allowed to dry prior to prineo mesh application? n/a.Please describe how the adhesive was applied on the tape? tape was applied over the incision flush and patted down to assure adherence.Was the mesh placed over the entire length of the incision? yes was the dermabond liquid adhesive placed to cover the entire length of the mesh? yes did the prineo mesh extend beyond the patient incision? yes.Was incision re-prepped before closure? if so, with what? if so, was the prep allowed to dry? n/a.Was the skin prep solution wiped off and let dry before applying adhesive? unknown.Was a dressing placed over the incision? if so, what type of cover dressing used? yes, mepilex standard.What date did the reaction occur on? before 3 weeks post-op.What does the reaction look like? please provide details.Reaction, raised erythema, rash.How large of an area does the reaction cover? the entirety of the mesh tape.Do you have any pictures of the reaction? yes, attached.What was done to address the reaction? removed the prineo and prescribed a steroid cream.What type of medication was used to treat the reaction? clobetasol.What was the dosage?.05% when (date) was the medication administered? 3 weeks post op.Was the product removed? was another method used to close the incision? yes.No.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? none known to cyanoacrylates or formaldehyde.Is the patient hypersensitive to pressure sensitive adhesives? none known.Were any patch or sensitivity tests performed? no.Can you identify the lot number of the product that was used? no.

Event Description

It was reported that the patient underwent a total hip replacement procedure on (b)(6) 2016 and the topical skin adhesive was applied on the skin with one layer.Chloraprep was used prior to application.It was also reported that cover mepilex dressing was placed over the incision.Before three weeks post-op, the patient experienced a skin reaction, severe itching, raised erythema and rash.The topical skin adhesive was removed and reaction was treated with 0.05% clobetasol cream.

• 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: kenneth clark ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183547
• MDR Report Key: 6017020
• MDR Text Key: 56974348
• Report Number: 2210968-2016-14308
• 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: 09/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/22/2016
• Initial Date FDA Received: 10/11/2016
• 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
• Treatment: MEPILEX STANDARD
• Patient Outcome(s): Required Intervention