MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 60CM MSH 3.8ML ADHESIVE SURGICAL SEALANT

Model Number CLR602US

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

Patient Problem Rash (2033)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4). The following information has been requested however not obtained to date. To date the device has not been received. If the further details are received at a later date a supplemental medwatch will be sent. Date of procedure? date of reaction? are any photos of the reaction available? what product was used prineo clr602 or another? what prep was used prior to, during or after adhesive use? please describe how was the adhesive was applied. Was a dressing placed over the incision? if so, what type of cover dressing used? it was noted steroid cream was prescribed, type and dosage? was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify. 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? patient demographics: initials / id, gender, age or date of birth; bmi? patient pre-existing medical conditions (ie. Allergies, history of reactions), does the patient use or exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? what is the most current patient status?.

Event Description

It was reported a patient underwent an spine surgery on unknown date in 2020 and topical skin adhesive with mesh was used. Post operatively the patient presented with a skin rash where the adhesive mesh was applied to the incision. The patient was treated with a steroid cream. The patient is doing fine. Additional information has been requested.

• Brand Name: DERMABOND PRINEO 60CM 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: 10842420
• MDR Text Key: 216318671
• Report Number: 2210968-2020-09053
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152490
• 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: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: CLR602US
• Device Catalogue Number: CLR602US
• 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: 10/23/2020
• 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: 11/16/2020 Patient Sequence Number: 1