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 Problems Necrosis (1971); Local Reaction (2035); Blister (4537)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been requested and obtained.Do you have any pictures of the reaction? no.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription medication? if so, please specify.N/a.If medication was required, please clarify if it was prescribed or purchased over-the-counter.N/a.What is the most current patient status? full recovery.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? additional information provided by rn: our patients usually wear it for 4-6 weeks post op and may shower with it insitu once their drains are removed.I am pleased to say - all patients are fine now.We have occasionally seen reactions using prineo in the past and a few times - when a patient has had a secondary revisional surgery (but did not react the first time using prineo).We check our patients frequently after an abdominoplasty at 1 week, 2 weeks, 3 weeks, 6 weeks, 3 months, 6 months, 1 year.They have drains initially, which remain until the drainage is very minimal on each side ie (less than 10 mis ), then they wear compression tights and a binder for at least 6 weeks post operatively.After prineo is removed, the patients use 1¿ brown micropore tape along the length of the scar until 12 week post op.We have not changed anything in our surgical technique, application of prineo dressing, or post op management during this time, so that is why i contacted you as we were unsure of why these incidents occurred all round the same time.In the past 6 weeks however we have not had any further incidents at all.To avoid pressure though, we have started leaving a little gap at the centre of the abdominal suture line to avoid pressure there.We will watch closely for any further issues.Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent what date did the reaction occur on? please describe how was the adhesive was applied.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? patient demographics: id, gender, age or date of birth; bmi? does the patient use or exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? was prineo/dermabond skin adhesive used on the patient in a previous surgery or wound closure? no product is available for return.

Event Description

It was reported a patient underwent an abdominoplasty on (b)(6) 2021 and topical skin adhesive was used.The patient had a skin reaction with blistering.Upon removal of adhesive there was small pressure necrosis breakdown of skin.Patient¿s wound had to be debrided and dressed.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: 12310185
• MDR Text Key: 268482413
• Report Number: 2210968-2021-07248
• 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: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: CLR422
• Device Lot Number: QJBASK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention