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

Catalog Number CLR222US

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 10/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information: the actual device batch number associated with this event is not known.The customer reports the following two batch numbers: jlp402 and jgh188.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: initial procedure date ¿ (b)(6) 2016.Incision size? ¿ approx.26cm.Please provide details on how the product was applied? ¿ per ifu.Was the mesh placed over the entire length of the incision? - yes.Was the dermabond liquid adhesive placed to cover the entire length of the mesh? - yes.Did the prineo mesh extend beyond the patient incision? - yes.Was a dressing placed over the incision? if so, what type of cover dressing used? - no.What was done to address the patients pain? any medications prescribed? ¿ not reported.Was the product removed? was another method used to close the incision? ¿ yes, not reported.Lot number involved ¿ jlp402 & jgh188.What is the physicians opinion of the contributing factors to the event? ¿ not reported.What is the most current patient status? ¿ not reported.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 ¿ not reported.Patient pre-existing medical conditions ¿ not reported.Attempts are being made to obtain the following additional information: the two lot numbers provided are related to clr222us.Please clarify is the product code involved clr602us or clr222us? were 2 prineo products used on the patient?.

Event Description

It was reported that a patient underwent a c-section procedure on (b)(6) 2016 and topical skin adhesive was used.Four days after the procedure, the device folded over horizontally.The device stuck to the patient¿s incision causing the patient pain.The device was removed.It is unknown how the incision was closed.Additional information has been requested.

Manufacturer Narrative

A review of the batch manufacturing records was conducted for the lots and the batch met all finished goods release criteria.Additional information was requested and the following was obtained: please clarify is the product code involved clr602us or clr222us? clr222us was the product code used.Were 2 prineo products used on the patient? yes, 2 were required on this patient to cover the incision.

• 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: 6059452
• MDR Text Key: 58451287
• Report Number: 2210968-2016-14536
• 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,Followup
• Report Date: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CLR222US
• Device Lot Number: JLP402
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2016
• Was Device Evaluated by Manufacturer?: No
• 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