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

Model Number CLR222

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

Patient Problems Inflammation (1932); Skin Irritation (2076); Tissue Damage (2104); Not Applicable (3189)

Event Date 11/18/2019

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. How was the wound reaction managed? how was the reaction treated (prescription steroids; antibiotics prescribed)? please describe how was the adhesive applied on the tape. What prep was used prior to, during or after prineo use? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? is the patient hypersensitive to pressure sensitive adhesives? were any patch or sensitivity tests performed? what is the physicians opinion of the contributing factors to the reaction? what is the most current patient status? is the product or representative sample (product from the same lot number) available for evaluation? patient demographics: initials / id; age or date of birth; bmi ; gender. Patient pre-existing medical conditions (ie. Allergies, history of reactions). Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure?.

Event Description

It was reported that the patient underwent total knee replacement on (b)(6) 2019 and topical skin adhesive was used. Post-operatively, the patient experienced a skin reaction at the surgical site aligned with the topical skin adhesive. The patient was re-admitted to manage wound reaction and superficial site infection risk. The patient experienced mild blisters and inflammation. The topical skin adhesive was removed and patient received wound reaction management. The surgeon opined they do not believe the patient experienced a true topical skin adhesive reaction and much of the redness was pink prep left under the topical skin adhesive. Following immediate removal of the topical skin adhesive, the patient progress was reported as very well. 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
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9445556
• MDR Text Key: 185480690
• Report Number: 2210968-2019-90728
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031237339
• UDI-Public: 10705031237339
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K133864
• 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: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: CLR222
• Device Catalogue Number: CLR222
• 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: 01/17/2020
• 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: 12/10/2019 Patient Sequence Number: 1