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 Reaction (2414); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported that the patient underwent a total knee replacement procedure on unknown date and topical skin adhesive was used.It was also reported that, during the procedure, betadine pre-op was used then the surgeon performed subcuticular closure, cleaned incision with water, dried and applied the mesh then topical skin adhesive was applied as a single application from the top of incision down.The surgeon also used a standard skin prep technique with chloraprep, left to dry, open incision closed, cleaned with saline solution and used ace bandage then removed 12-24 hour post op and tried to control swelling.Following the procedure, the patient developed blisters at ends of incision, beneath the mesh or possibly spread out beyond the mesh.The surgeon opines that blisters appear with serous fluid and more like a mechanical reaction.When reaction was observed, it was possible that the mesh was left in the place or peeled back and trimmed.The patient experienced possibly erythema and some discoloration with no residual effect.The patient was treated locally and possibly given oral antibiotics with bactrim to address the reaction.

• 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: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 5476566
• MDR Text Key: 39560102
• Report Number: 2210968-2016-05619
• 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: 02/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• 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: 02/11/2016
• 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
• Patient Outcome(s): Required Intervention