MAUDE Adverse Event Report: ETHICON INC. PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT; SURGICAL SEALANT

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

Patient Problems Wound Dehiscence (1154); Cellulitis (1768); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts are being made to obtain the following information.To date no response has been provided.If further details and or the device are received at a later date a supplemental medwatch will be sent.Do you have any photos? procedure name? procedure date? what is product code and code and lot number? can you describe the cellulitis reaction? how did patient appear at the 1 week follow up? does the surgeon believe this was hypersensitivity reaction? what date did the reaction occur post op? what prep was used prior to, during or after prineo use? how many layers of adhesive were used over the prineo mesh during application? 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? were any patch or sensitivity tests performed? what is the physicians opinion of the contributing factors to the reaction? patient demographics: initials / id; age or date of birth; bmi; gender? patient pre-existing medical conditions (ie.Allergies, history of reactions)? for female patients ask: was the patient exposed to similar products, such as artificial 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 to a patient underwent and unknown procedure in 2019 and topical skin adhesive was used.Patient showed cellulitis around the topical skin adhesive about 2-4 weeks post operatively.Patient was admitted to the hospital.It was difficult to see there was a dehiscence and patient was taken back for debridement and redo wound closure.Additional information requested.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
• Type of Device: SURGICAL SEALANT
• 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: 8479425
• MDR Text Key: 140810239
• Report Number: 2210968-2019-79959
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2019
• 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): Hospitalization; Required Intervention