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 Hypersensitivity/Allergic reaction (1907); Local Reaction (2035)

Event Date 01/01/2021

Event Type  Injury  

Event Description

It was reported a patient underwent an unknown breast procedure on an unknown date in 2021 and topical skin adhesive was used.The patient has had a reaction/skin sensitivity to adhesive.Treated with benadryl or steroids.Additional information has been requested.

Manufacturer Narrative

(b)(4).Additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.If this event occurred in multiple procedures, please provide the following information for each patient event: unknown.What is the procedure name? breast surgery, revisions.What is the procedure date? time frames june - august 2021.What date did the reaction occur on? during the period approximately of june-august - unknown exactly dr.Would have to look in his charts.What does the reaction look like and how large of an area does the reaction cover? image.Do you have any pictures of the reaction? yes.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription medication)? if so, please specify.If medication was required, please clarify if it was prescribed by a physician.Some treated with benadryl - or with steroids.What is the most current patient status? patients are fine.Can you identify the product code and lot number of the product that was used? no.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? some patients had surgery with either prineo or dermabond.The single complaint was reported with multiple events.There are no additional details regarding the additional events.No product is available for return.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
• Type of Device: SURGICAL SEALANT
• 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: 12780331
• MDR Text Key: 285074290
• Report Number: 2210968-2021-11128
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• 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: 10/11/2021
• 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