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); Cellulitis (1768); Fever (1858); Inflammation (1932); Necrosis (1971); Swelling (2091); No Code Available (3191)

Event Date 09/06/2016

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.

Event Description

It was reported that the patient underwent a total knee arthroplasty procedure on (b)(6) 2016 and the topical skin adhesive was used after multi-layered closure followed by an abd dressing and ace wrap.Post-operatively, the patient noticed blistering and it was evaluated by a doctor on the skin both medial and lateral under the topical skin adhesive on (b)(6) 2016.Blisters were aspirated for serosanguinous drainage and cultures were negative.The topical skin adhesive was left in a place and sloughed off spontaneously.The patient was evaluated with some improvement on (b)(6) 2016.Last week, the patient was admitted to the hospital with possible cellulitis and further evaluation and treatment of were indicated.The patient had come down with a 103 degree fever, and his knee swelled up.The wound edges had become necrotic and have shown complete dehiscence.The patient will now need a debridement, wound vac, and skin grafting.Now the patient is being refered to a specialist to continue a treatment.

• 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: 6077246
• MDR Text Key: 59114694
• Report Number: 2210968-2016-14709
• 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: 09/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• 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: 10/13/2016
• 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: ACE WRAP, ABD DRESSING
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR