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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Skin Irritation (2076)

Event Date 01/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.(b)(4).Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.How was the device applied to the incision? what layer of tissue and how many layers applied? what prep was used prior to product application? what was the location and incision size of the application? was a dressing placed over the incision? if so, what type of cover dressing used? do you have any pictures of the reaction? please clarify if the cortisone cream was an otc product or prescription medication.Can the product code and lot number of the product be identified? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? for female patients, were they exposed to similar products, such as artificial nails? what is the most current patient status? patient demographics: initials / id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i.E.Allergies, history of reactions).Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure?.

Event Description

It was reported that the patient underwent a gastric sleeve procedure on (b)(6) 2018 and topical skin adhesive was used.The patient reported an allergic reaction to the topical skin adhesive.She has six small wounds and around each wound, there is a 3 cm red halo that is extremely itchy.The patient has no temperature and she has been checked by the surgeon and confirmed that it is not an infection.The patient spoke to the doctor on (b)(6) 2018 when the welts became bigger and extremely itchy.The doctor removed the topical skin adhesive with petroleum jelly.Cortisone cream has been applied.No further information is available.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC; route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.SAN LORENZO; 982 road 183 km 8.3; san lorenzo PR 00754
• Manufacturer Contact: darlene kyle ; route 22 west; somerville, NJ 00876 ; 9082182792
• MDR Report Key: 7252603
• MDR Text Key: 99377276
• Report Number: 2210968-2018-70753
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention