MAUDE Adverse Event Report: ETHICON INC. PRINEO SKIN CLOSURE SYSTEM; SURGICAL SEALANT

Catalog Number CLR602

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Wound Dehiscence (1154); No Code Available (3191)

Event Date 10/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent a dermolipectomy procedure on (b)(6) 2016 and the topical skin adhesive was used.Following the procedure, the patient experienced a wound dehiscence.The patient was hospitalized and the vacuum dressing was applied.There is no infection.It was necessary to remove the topical skin adhesive earlier than expected and the thread was removed where there was dehiscence.It was also reported that the patient will remain in the hospital one more week.The doctor performed an intervention in the surgical wound on (b)(6) 2016, and re-made the suture, closing the incision.It was informed by a nurse that likely the patient will be discharged on (b)(6).Additional information has been requested.

Manufacturer Narrative

Additional information was requested and the following was obtained: was there any patient event prior to the dehiscence (cough, fall)? no.Was there any deficiency noted with the prineo before, during or post operatively? no.During the procedure he was present and the patient did not present any intercurrence / problem.The doctor informed that he had to remove the prineo, because it was coming out an exudate.Patient pre-existing medical conditions - patient had a bariatric procedure.Dr.(b)(6) performed an intervention in the surgical wound yesterday and remade the suture, closing the incision.He made a subdermal suture with vicryl 3-0 and 4-0 and intradermal with simple stitch of mononylon 5-0.The nurse who is taking care of the vacuum dressing made the dressing at the end of the procedure and informed that likely he will be discharged on thursday.How is the patient¿s current condition? the patient is well / ok.

• 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: 6081219
• MDR Text Key: 59281012
• Report Number: 2210968-2016-14749
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2018
• Device Catalogue Number: CLR602
• Device Lot Number: KDH174
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/17/2016
• Initial Date FDA Received: 11/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/02/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/13/2016
• 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: STRATAFIX SPIRAL PGA-PCL
• Patient Outcome(s): Hospitalization; Required Intervention