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 Problem Hypersensitivity/Allergic reaction (1907)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The following information has been requested however not received.To date the device has not been received.If the further details are received at a later date a supplemental medwatch will be sent.Date of surgery? date of reaction? please detail type and dosage of steroids prescribed.Please describe how the adhesive was applied.What prep was used prior to, during or after prineo use? 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? is the patient hypersensitive to pressure sensitive adhesives? were any patch or sensitivity tests performed? patient demographics: initials / id, gender, age or date of birth; bmi patient pre-existing medical conditions (ie.Allergies, history of reactions) has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? can you identify the lot number of the product that was used? what is the current status of the patient? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported a patient underwent a total knee procedure on an unknown date and a topical skin adhesive with mesh was used.Post-operatively the patient developed dermatitis around the incision where adhesive was applied.The reaction spread up the leg and on to the stomach.Patient treated with oral and topical steroids and benadryl.The patient had symptoms after three weeks.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(6).Date sent to fda: 1/28/2021.Additional information: g1.The following information has been requested however not available.To date the device has not been received.If the further details are received at a later date a supplemental medwatch will be sent.Date of surgery? na date of reaction? na what prep was used prior to, during or after prineo use? na.Was a dressing placed over the incision? if so, what type of cover dressing used? na is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? na is the patient hypersensitive to pressure sensitive adhesives? na were any patch or sensitivity tests performed? no patient demographics: initials / id, gender, age or date of birth; bmi no patient pre-existing medical conditions (ie.Allergies, history of reactions) na does the patient use or exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails) na was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? na can you identify the lot number of the product that was used? na the following information has been requested and obtained.Please detail type and dosage of steroids prescribed.Na on dosage of steroids but topical and oral steroids along with benadryl.Please describe how the adhesive was applied.When speaking to the pa, all application steps were followed correctly.However, no rep was in the room because they have been using prineo for a while now.What is the current status of the patient? unsure ¿ will continue to follow up with staff this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 5/17/2021.Additional information: h6health effect - impact code additional information received: staff told rep on a recent visit that patient had to go back for a wash out.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Product complaint #(b)(4).Date sent to the fda: 5/17/2021 this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.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 08876
• MDR Report Key: 11089906
• MDR Text Key: 224800183
• Report Number: 2210968-2020-10370
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 01/07/2021; 04/21/2021
• Supplement Dates FDA Received: 01/28/2021; 05/17/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention