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

Catalog Number CLR222US

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

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

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The following additional information has been requested however not received to date: initial date of tkr? it was noted that 3 weeks post op the wound dehiscenced, what was the date? was the prineo in place at the time of the dehiscence? what medical / surgical treatment was provided to treat the dehiscence? lot number? what prep was used prior to, during or after prineo use? how many layers of adhesive were used over during application? was a dressing placed over the incision? if so, what type of cover dressing used? what is the physicians opinion of the contributing factors to the dehiscence? patient demographics: initials / id; age or date of birth; bmi.The following response has been obtained: no further information has been provided other than nurse practitioner commenting this was a non-compliant patient during post operative recovery and also again when readmitted from skilled nursing facility.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 a total knee replacement procedure on an unknown date in (b)(6) 2019 and topical skin adhesive was used.Patient was readmitted from a skilled nursing facility with a wound dehiscence, three weeks post operatively.Unknown if adhesive was still on at time of admission.Patient has history of anxiety and alcohol abuse.Additional information has been 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 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 9145344
• MDR Text Key: 161004665
• Report Number: 2210968-2019-88298
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2019
• 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