MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE CUTANEOUS TISSUE ADHESIVE WITH MESH

Model Number CLR422US

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

Patient Problems Erythema (1840); Unspecified Infection (1930); Inflammation (1932); Swelling (2091); Not Applicable (3189)

Event Date 08/01/2020

Event Type  Injury  

Manufacturer Narrative

(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. The patient demographic info: age, gender, weight, bmi at the time of index procedure? date of the index surgical procedure? the diagnosis and indication for the index surgical procedure? on what tissue were the stratafix symmetric devices used? on what tissue were the stratfix spiral devices used? what device(s) were used on the patient¿s incision? were there any pre-existing signs/ symptoms of active infection prior to the surgical procedure? did the patient receive any prophylactic antibiotics pre, intra- or post-operation? were cultures performed? results? which tissue layer was infection observed? where and how was the prineo device used (what layer of tissue and how many layers applied)? has the patient had prior exposure to prineo or other skin adhesives? has the patient demonstrated previous hypersensitivity or allergies to cyanoacrylate or formaldehyde? does the patient have allergies to medication, food, etc? was an allergy test performed? result? describe the location and appearance of the redness and inflammation. Were any photos taken ? other relevant patient history/ concomitant medications? lot number of the prineo, stratafix symmetric and stratafix spiral devices? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status? note: events submitted via mw # 2210968-2020-06455, 2210968-2020-06456, 2210968-2020-06457, 2210968-2020-06458.

Event Description

It was reported that the patient underwent total knee replacement on an unknown date and topical skin adhesive was used. Following the procedure, the surgeon noted patient had redness, swelling and general unwell looking incision. It was reported suspected infection and patient was admitted to care facility and not seeming to respond to antibiotics. The surgeon opined issue is with incision and patient has had redness since day one. Additional information has been requested.

• Brand Name: DERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE
• Type of Device: CUTANEOUS TISSUE ADHESIVE WITH MESH
• 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
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10464939
• MDR Text Key: 204705229
• Report Number: 2210968-2020-06454
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K163645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: CLR422US
• Device Catalogue Number: CLR422US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/28/2020 Patient Sequence Number: 1