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 Discharge (2225); Organ Dehiscence (2502); Blood Loss (2597); No Code Available (3191)

Event Date 02/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Conclusion: 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.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Event Description

It was reported that the patient underwent a knee procedure on unknown date and topical skin adhesive was used.The patient was prepped prior to incision with chloraprep and, in addition, the surgeon used tranexamic acid prior to wound layer closure to help mitigate bleeding.Prior to topical skin adhesive application, wound was cleaned with normal saline and then dried.During the procedure, the incision was dry and not oozing blood.It was also reported that after topical skin adhesive was applied, there was some oozing in one location.This was controlled with compression, the location was dried, additional liquid was applied and oozing stopped.Two days post-operatively, the patient experienced bleeding and oozing.The oozing, the patient was experiencing post op, appeared to be coming from the same location.The surgeon opines that topical skin adhesive should provide a tight seal, not allowing fluid to escape.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: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 5496254
• MDR Text Key: 40199515
• Report Number: 2210968-2016-06086
• 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: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2017
• Device Catalogue Number: CLR222US
• Device Lot Number: JHR782
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2015
• 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