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

Catalog Number CLR422

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

Patient Problem Local Reaction (2035)

Event Date 05/25/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been requested and obtained.If further details are received at a later date a supplemental medwatch will be sent.What is the procedure date? not provided.What date did the reaction occur on? exact date not provided, all reactions were approx 5-6 weeks post-op.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription medication)? if so, please specify.No, only topical steroid applied.If medication was required, please clarify if it was prescribed or purchased over-the-counter.Prescribed.What is the most current patient status? not known.Can you identify the lot number of the product that was used? not provided.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? not provided.Unfortunately no further information is available from hcp for this reported case.Please describe how was the adhesive was applied.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? is the patient hypersensitive to pressure sensitive adhesives? were any patch or sensitivity tests performed? patient demographics: id, gender, age or date of birth; bmi.Has the patient previously been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? unfortunately no further information is available from hcp for this reported case.No product available for return.Note: events reported on mw# 2210968-2021-07852, mw# 2210968-2021-07853, mw# 2210968-2021-07854.

Event Description

It was reported a patient underwent a total knee replacement on unknown date and topical skin adhesive was used.Post op 5-6 weeks, patient suffered atopic contact dermatitis after having adhesive used on their skin.Reaction noticed post-surgery.Prescription topical steroid applied.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.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12393116
• MDR Text Key: 268979538
• Report Number: 2210968-2021-07855
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K163645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CLR422
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention