MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM SKIN CLOSURE; SURGICAL SEALANT

Catalog Number CLR222US

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 01/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested and the following was obtained: did the wound dehisce? no.Did the prineo come off prematurely? yes.Was there any medical or surgical intervention performed? reclosure with application of a wound vac.What is the most current patient status? stable.Can you identify the lot number of the product that was used? n/a.Location and incision size of product application? n/a.What prep was used prior to prineo use? prineo was applied to dry wound edges at the conclusion of the case after a dermal closure was performed with a 2-0 vicryl.A single layer of prineo was applied.Please describe how the adhesive was applied on the tape? n/a.Was incision re-prepped before closure? if so, with what? n/a.Was a dressing placed over the incision? if so, what type of cover dressing used? n/a.What is the appearance of drainage (clear, purulent, serous)? n/a.Type of skin preparation used? n/a.Physicians opinion of the factors contributing to the event? ¿i am very concerned about this failure of the technology.I anticipated that the technology may fail in draining wounds, as the drainage could build up under the mesh and cause disruption of the bond between the mesh and the skin surface.¿.

Event Description

It was reported that a (b)(6) year old female underwent a primary posterior cervical fusion procedure and topical skin adhesive was used.The topical skin adhesive was applied to the dry wound edges at the conclusion of the case after a dermal closure was performed with suture.A single layer of topical skin adhesive was applied.The woman¿s drain was removed, prior to that she had no drainage and once the sub fascial drain was removed there was some seepage through the incision.When the wound was checked on pod2, the topical skin adhesive was noted to have pulled off of the wound edges.The patient underwent reclosure and wound vac was applied to the incision.The surgeon anticipated that the technology may fail in draining wounds, as the drainage could build up under the mesh and cause disruption of the bond between the mesh and the skin surface.The patient current status is stable.Additional information was requested.

• Brand Name: DERMABOND PRINEO 22CM SKIN CLOSURE
• 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; road 183, km. 8.3; san lorenzo PR 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8283945
• MDR Text Key: 134402448
• Report Number: 2210968-2019-78605
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• Combination Product (y/n): N
• 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: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR