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

Catalog Number CLR422

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

Patient Problems Erythema (1840); Skin Irritation (2076); No Code Available (3191)

Event Date 05/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information has been requested, and the following was obtained: what prep was used prior to, during or after prineo use? cetrimide pre-op wash.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? no.Is the patient hypersensitive to pressure sensitive adhesives? query mention of sensitivity in the past to tapes with a previous surgeon.Were any patch or sensitivity tests performed? no.Do you have the product lot number involved? see impacted product.What is the physicians opinion of the contributing factors to the reaction? n/k.What is the most current patient status? tba.Is the product or representative sample (product from the same lot number) available for evaluation? no.Patient demographics: initials / id; age or date of birth; bmi ; gender: provided in initial report.Patient pre-existing medical conditions (ie.Allergies, history of reactions) query mention of sensitivity in the past to tapes with a previous surgeon.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? no, not with dr ¿ she has had surgery with other surgeons so unable to say 100%.To date device not received.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported a patient underwent a revision abdominoplasty to repair hernia on an (b)(6) 2019 and topical skin adhesive was used.3 days post operatively, the patient had a reaction to the adhesive dressing.The patient had redness, bumps and secretion for the wound.The patient's dressing was removed and the patient was placed on corticosteroid treatment, prescribed bactrim and prednisolone.The area was re-dressed with mefix tape additional information was requested.

• Brand Name: DERMABOND PRINEO 42CM
• Type of Device: CUTANEOUS TISSUE ADHESIVE WITH MESH
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8670827
• MDR Text Key: 147064225
• Report Number: 2210968-2019-82415
• 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: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: CLR422
• Device Lot Number: MGH123
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR