MAUDE Adverse Event Report: ETHICON INC. PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT; SURGICAL SEALANT

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

Patient Problems Skin Irritation (2076); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Were 2 prineo products used on the patient? what was the product code and lot number of prineo used? was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? what prep was used prior to, during or after prineo use? was a dressing placed over the incision? if so, what type of cover dressing used? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? what is the physicians opinion of the contributing factors to the reaction? what is the most current patient status? patient demographics: initials / id; age or date of birth; bmi ; gender patient pre-existing medical conditions (ie.Allergies, history of reactions).

Event Description

It was reported that a patient underwent a bilateral hip replacement procedure in (b)(6) 2019 and topical skin adhesive with mesh was used.The patient experienced discomfort at the surgical site for the first few days after surgery and had to go back to the surgeon to see what the problem was.When the surgeon removed the dressing, he saw what he felt was our topical skin adhesive with mesh.It was a long strip of mesh centered over the incision.The skin underneath was red and raised at the surgical site.Additional information was requested.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: were 2 prineo products used on the patient? two prineo products were used, one on each incision following bilateral total hip replacement using an anterior approach.What was the product code and lot number of prineo used? product code/lot # ? i don¿t know.Was prineo demabond or skin adhesive used on the patient in a previous surgery or wound closure? prineo/dermabond were not used previously on the patient for surgery or wound closure.What prep was used prior to, during or after prineo use? not sure what prep was used.Was a dressing placed over the incision? if so, what type of cover dressing used? dressings were placed over both incisions, not sure what type.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? patient had no known hypersensitivity or allergies to cyanoacrylate or formaldehyde prior to this episode.What is the physicians opinion of the contributing factors to the reaction? physician said the prineo/dermabond caused the reactions, locally at the incision sites, and elsewhere on the body where severe itchy rashes formed.What is the most current patient status? currently (5 weeks post-op) the incision sites appear to be healing, but there are still rashes/severe itching elsewhere on the body.Patient demographics: initials / id; age or date of birth; bmi ; gender ? patient demographics: mgd, age 59, male.Patient pre-existing medical conditions (ie.Allergies, history of reactions) pre-existing medical conditions: allergic to penicillin.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8340307
• MDR Text Key: 136179523
• Report Number: 2210968-2019-78883
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• PMA/PMN Number: K082289
• 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: 01/20/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/20/2019
• Initial Date FDA Received: 02/14/2019
• Supplement Dates Manufacturer Received: 02/21/2019; 02/21/2019
• Supplement Dates FDA Received: 03/07/2019; 03/07/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR