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 Unspecified Infection (1930); Inflammation (1932); Discharge (2225); Reaction (2414); No Code Available (3191)

Event Date 10/08/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) date sent to fda: 11/28/2016.(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: procedure date ¿ (b)(6) 2016.Location and incision size of product application? total knee.What prep was used prior to prineo use? betadine.Was the prep allowed to dry prior to prineo mesh application? as per ifu.Please describe how the adhesive was applied on the tape? as per ifu.Was the dermabond liquid adhesive placed to cover the entire length of the mesh? as per ifu.Did the prineo mesh extend beyond the patient incision? as per ifu.Was incision re-prepped before closure? if so, with what? if so, was the prep allowed to dry? unknown.Was the skin prep solution wiped off and allowed to dry before applying adhesive? unknown.Was a dressing placed over the incision? if so, what type of cover dressing used? unknown.Date of reaction ¿ (b)(6) 2016.What does the reaction look like? it was reported that the reaction was more like an inflammatory allergic reaction.The doctor has photos, however will not release.How large of an area does the reaction cover? unknown.Did the skin reaction extend beyond the borders of the tape? unknown.Were any cultures performed and the results? unknown.Do you have any pictures of the reaction? the doctor will not release the photos.What was done to address the reaction? antibiotics.What type of medication? dose? when (date) administered? unknown.Were any other medications prescribed and were they topical or oral? unknown.Was the product removed? was another method used to close the incision? unknown.Was the site cultured? if so, what bacteria were identified? unknown.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unknown.Is the patient hypersensitive to pressure sensitive adhesives? unknown.Were any patch or sensitivity tests performed? unknown.Lot number involved ¿ unknown.Update to patient current condition ¿ patient is healed and doing fine.Details regarding previous cases ¿ the doctor does not remember any specifics about previous cases.The single complaint was reported with multiple events.There are no additional details regarding the additional events.

Event Description

It was reported the patient underwent a total knee procedure on (b)(6) 2016 and topical skin adhesive was used.Following the procedure, the patient experienced possible wound infection, pus and inflammatory allergic reaction.The doctor prescribed antibiotics and special treatment for the infected wound.The doctor opines that the patient had an allergic reaction to topical skin adhesive and the polyester mesh.It is reported that the patient has healed and is doing fine.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: 6130146
• MDR Text Key: 60963860
• Report Number: 2210968-2016-15158
• 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: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• 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: 11/08/2016
• 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