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 Tissue Damage (2104); Not Applicable (3189)

Event Date 09/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4). The following information has been requested and the following was received. To date the device has not been received. If the further details are received at a later date a supplemental medwatch will be sent. Are there any photos available? no. Date of procedure? unsure. Date of event/blister/hospitalization? unsure they never told me. What medical and or surgical intervention was provided to address the issue? treatment of blistering with creams. Please describe how was the adhesive was applied. It was applied correctly according to ifu. What prep was used prior to, during or after prineo use? normal prep. Was a dressing placed over the incision? if so, what type of cover dressing used? sponges and taped over sponges not the prineo. Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? apparently yes. Is the patient hypersensitive to pressure sensitive adhesives? possibly. Were any patch or sensitivity tests performed? no. Patient demographics: initials / id, gender, age or date of birth; bmi female patient pre-existing medical conditions (ie. Allergies, history of reactions) unsure. Does the patient use or is the patient exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? unsure. Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? no. Current patient status. She has recovered.

Event Description

It was reported a patient underwent a total knee replacement on an unknown date and topical skin adhesive was used. Post operatively, the patient presented a few days later with blistering. The patient was readmitted. No other information is available. No device will be returned. 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 ; 00754
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10708501
• MDR Text Key: 212350615
• Report Number: 2210968-2020-08163
• Device Sequence Number: 1
• Product Code: OMD
• 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

• Type of Report: Initial
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: CLR222US
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/30/2020
• 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: 10/20/2020 Patient Sequence Number: 1