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

Catalog Number CLR222

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Patient-Device Incompatibility (2682)

Patient Problems Wound Dehiscence (1154); 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 information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested and the following was obtained: date the event occurred? n/k.Please confirm was is meant be insufficient closure? is this technique related or improper closure? technique related.Dr (b)(6) advised that there were a few factors that "has" contributed: prineo being removed too early by staff or moisture and rolled off (re-trained); insufficient closure leaving dead space (re-trained assistant).Is the wound dehiscence being attribute to the stratafix? no.Did the patient have any pre-existing health issues that could contribute to healing issues which could have contributed to the event? for example, medications, past reactions or allergies, weight, age, diabetes, obesity, etc? n/k.Did the patient fall or injury themselves in a way that may have affected the surgical area? no.Was the patient compliant with post-op instructions? n/k.What type of medical intervention was provided by the surgeon? what precisely was done as part of the intervention? re-closure.What is the patient¿s current condition? tba.How long post-op did the patient present with symptoms for each of the cases? approx 2 weeks.Has surgeon been trained on the product? yes.What is the procedure name and initial procedure date? spinal procedure.What date did the dehiscence occur on? about 2 weeks post-op.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.Re-closure.What is the most current patient status? n/k.Can you identify the product code and lot number of the product that was used? tba.Additional information was requested and the following was obtained: was there any alleged product deficiency relating to the prineo? reason that the prineo was accidently removed/ rolled off or removed? product code and lot number of prineo used? was there any stratafix suture deficiency (breakage) noted related to the wound dehiscence? please explain what layer experienced the wound dehiscence? was there any alleged product deficiency relating to the stratafix suture? will actual samples be returned for evaluation? will any unopened representative samples be returned for evaluation?.

Event Description

It was reported that a patient underwent a spinal procedure on an unknown date and topical skin adhesive was used.Approximately two weeks post op, the patient came back with wound dehiscence.The topical skin adhesive may have been removed accidently by agency staff at ward or rolled off due to moisture/sweat too early.The patient was resutured.The surgeon used barbed suture for fascia and muscle and another barbed suture for subcutaneous/subcuticular closure.The surgeon used topical skin adhesive on skin.The surgeon reports that the wound dehiscence is not attributed to the barbed suture.The surgeon opines that the dehiscence is technique related or possibly due to insufficient closure leaving dead space in the subcutaneous layer or the topical skin adhesive being taken off at wards before its supposed to.The staff has been given thorough education.The surgeon has started to close fascia / muscle, subcutaneous and subcuticular with barbed suture.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to fda: 2/1/2019.Additional information was requested and the following was obtained: date the event occurred? n/k.Please confirm was is meant be insufficient closure? is this technique related or improper closure? technique related.Dr advised that there were a few factors that has contributed.Prineo being removed too early by staff or moisture and rolled off (re-trained).Insufficient closure leaving dead space (re-trained assistant) since addressing these issues, patients all healing well.Is the wound dehiscence being attribute to the stratafix? no.Did the patient have any pre-existing health issues that could contribute to healing issues which could have contributed to the event? n/k.Did the patient fall or injury themselves in a way that may have affected the surgical area? no.Was the patient compliant with post-op instructions? yes.What type of medical intervention was provided by the surgeon? what precisely was done as part of the intervention? re-closure.What is the patient¿s current condition? no further complications reported since re-closure.How long post-op did the patient present with symptoms for each of the cases? approx 2 weeks.Has surgeon been trained on the product? yes.What is the procedure name and initial procedure date? spinal procedure date not provided by surgeon's room.What date did the dehiscence occur on? about 2 weeks post-op.Was there any medical or surgical intervention performed - re-closure.What is the most current patient status? no further complications reported since re-closure.Can you identify the product code and lot number of the product that was used? clr222, sxpp1a404, sxmd1b408.Was there any wound infection? if yes, does the surgeon believe that any ethicon product (prineo/stratafix) contributed to the wound infection? no, the surgeon believes it was due to the insufficient closure due to technique that caused the wound infection.How many days post-op was the prineo removed.Accidentally/rolled off or removed by dr (b)(6)? surgeon only advised that the dermabond rolled off a couple of days post-op but did not advised specific days to jjm rep.Was there any alleged product deficiency relating to the prineo? no.Reason that the prineo was accidently removed/ rolled off or removed? rolled off believe to be from moisture of infection product code and lot number of prineo used? clr222.Was there any stratafix suture deficiency (breakage) noted related to the wound dehiscence? no.Please explain what layer experienced the wound dehiscence? fascia and muscle, subcutaneous/subcuticular.Was there any alleged product deficiency relating to the stratafix suture? no.Will actual samples be returned for evaluation? no, discarded.Will any unopened representative samples be returned for evaluation? no.

• Brand Name: DERMABOND PRINEO 22CM
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8164804
• MDR Text Key: 130361314
• Report Number: 2210968-2018-77766
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: CLR222
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/27/2018
• Patient Sequence Number: 1
• Treatment: STRATAFIX SUTURE: SXPP1A404 AND SXMD1B408; STRATAFIX SUTURE: SXPP1A404 AND SXMD1B408
• Patient Outcome(s): Required Intervention