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); Unspecified Infection (1930); Necrosis (1971); Impaired Healing (2378); No Code Available (3191)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.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: please describe patient symptoms and date post operatively when symptoms began? eschar, dehiscence, infection ; happened in the last two weeks please describe any medical or surgical intervention that was done to address the patient issue? reoperation required.Open incision and wash out.Occasional wound vac necessary.What type of medication? dose? when (date) administered? aspirin, celebrex, hydrocodone.Was the product removed? if yes, please provide date and was another method used to close the incision? yes, different times depending on the severity of the wound.What prep was used prior to prineo use? cloroprep, i-o ban, wet, dry, then prineo.Please describe how the adhesive was applied on the tape? per ifu.Was incision re-prepped before closure? if so, with what? wet lap, then dry lap.Was a dressing placed over the incision? if so, what type of cover dressing used? ace bandage once dry.Was the site cultured? if so, what bacteria were identified? yes, unknown.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? no.Is the patient hypersensitive to pressure sensitive adhesives? no.Were any patch or sensitivity tests performed? no.Lot number involved ¿ no answer.What is the physicians opinion of the contributing factors to the patient event? doctor and pa.Think that the prineo is not sufficiently allowing drainage to occur therefore causing pressure to build up.Thinking also prineo mesh might be seeping into the incision itself preventing healing.What is the most current patient status? unknown.Is the product or representative sample (product from the same lot number) available for evaluation? no.Patient demographics: initials / id; age or date of birth; bmi ; gender ¿ not provided.Patient pre-existing medical conditions (ie.Allergies, history of reactions) ¿ not provided.Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? no answer.

Event Description

It was reported that a patient underwent a hip replacement procedure on an unknown date and topical skin adhesive was used.The patient returned with dehiscence and/or infection.It was also reported that the patient possibly developed eschar.The patients issue may have been addressed by reoperation, opening the incision, wash out and/or possible wound vac.The product may have been removed and a different method used to close the incision depending on the severity of the wound.The doctor opined that the topical skin adhesive was not sufficiently allowing drainage to occur therefore possibly causing pressure to build up and might be seeping into the incision, preventing healing.The patient's current status is unknown.

• 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: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6339105
• MDR Text Key: 67696548
• Report Number: 2210968-2017-30777
• 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: 02/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• 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: 02/03/2017
• 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