MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE; SURGICAL SEALANT

Model Number CLR222US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Not Applicable (3189)

Event Date 02/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts to obtain the following information has been performed and the following was received.If the further details are received at a later date a supplemental medwatch will be sent.When was the dehiscence diagnosed? intra-op or post-op? dihiscence post-op in phase 2 recovery please advise of date of initial procedure.Date of procedure (b)(6) 2020 was prineo used during initial procedure? prineo used at time of procedure? what date post op was wound dehiscence noted? (b)(6) 2020.If prineo used during initial procedure, what was the state of the prineo upon noting dehiscence? don¿t know.Were anomalies mentioned about mesh patch observed during initial procedure? don¿t know.Or post op while addressing dehiscence? don¿t know.Photo of dehiscence? no picture.Was there any other treatment provided (product removed; reoperation; prescription steroids; antibiotics prescribed) in addition to more adhesive? if so, please clarify don¿t know.Please indicate any medical or surgical interventions performed.None.Was patient placed under anesthesia to address dehiscence? no.Please describe how was the adhesive was applied.Don¿t know.What prep was used prior to, during or after prineo use? chloroprep.Was a dressing placed over the incision? if so, what type of cover dressing used? opsite 4x4¿s.What is the surgeon¿s opinion of the dehiscence and why it may have occurred? don¿t know.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.

Event Description

It was reported a patient underwent an circumferential belt lipectomy on (b)(6) 2020 and topical skin adhesive was used.During phase 2 recovery in post op, the patient had some dehiscence.They applied more adhesive.Case completed with another device of the same product code.No device will be returned.Additional information was requested.

• Brand Name: DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9884016
• MDR Text Key: 186547237
• Report Number: 2210968-2020-02384
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2020

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 Model Number: CLR222US
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/28/2020
• Initial Date FDA Received: 03/26/2020
• 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