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 Inflammation (1932); Rash (2033); Skin Irritation (2076); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts to obtain the following information have been made with no response to date.If further details are received at a later date a supplemental medwatch will be sent.Was hemostasis achieved prior to the application of prineo? was any oozing noted prior to the application of prineo? 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? patient demographics: initials / id; age or date of birth; bmi, patient pre-existing medical conditions (ie.Allergies, history of reactions).Patient current condition.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 total hip arthroplasty on an unknown date and topical skin adhesive was used.The patient was treated with antibiotics prescribed as a precaution in case of infection.The adhesive was removed 10 days post op, per usual protocol.Patient was brought back for debridement/wash-out after being seen 10 days post-op.Soft tissue turned black along incision and out of precaution to preserve implants the surgeon completed the secondary procedure.Patient is now fine.No implants were removed.Additional information has been requested.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(6).Additional information has been requested and obtained: what was used to close the subq layer of tissue? 3-0 stratafix spiral monocryl was hemostasis achieved prior to the application of prineo? yes, hemostasis was achieved.Was any oozing noted prior to the application of prineo? no oozing was noted prior to application of prineo.What prep was used prior to, during or after prineo use? dr.And team use, alcohol, chloraprep, duraprep and ioban on arthroplasty procedures.Area was cleaned/wiped off prior to prineo application.How many layers of adhesive were used over during application? 1 layer of adhesive was a dressing placed over the incision? if so, what type of cover dressing used? an opsite (a large bandage) is placed once prineo is dry.What is the physicians opinion of the contributing factors? the surgeon is unsure why this happened.Patient demographics: initials / id; age or date of birth; bmi, n/a patient pre-existing medical conditions (ie.Allergies, history of reactions) n/a.

• 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
• MDR Report Key: 9531841
• MDR Text Key: 185734499
• Report Number: 2210968-2019-91257
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• 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
• Date Manufacturer Received: 01/02/2020
• Patient Sequence Number: 1
• Treatment: STRATAFIX SPIRAL MONOCRYL PLUS UNKNOWN
• Patient Outcome(s): Required Intervention