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 Inflammation (1932); Tissue Damage (2104)

Event Date 01/01/2020

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.If in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide your surgeon¿s name and contact information and fill out the attached consent form? you mentioned this has already been reported to us by your surgeon, do you happen to know the file number? 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 replacement procedure on (b)(6) 2020 and topical skin adhesive with mesh was used.Post operatively, after removing the tape the patient had a serious skin reaction.It was inflamed, red and sore.The next day, patient's leg was inflamed and blistered.Patient was on prednisone and hydroxine for 2 weeks to treat.No device will be returned.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 12/11/2020.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 the patient noted the dr reported to ethicon, if it has been reported prior please provide the product complaint reference#.Are any photos of the reaction available? what product code and /or lot was used? what was the date of the reaction, day post op? it was noted steroids were prescribed, what other medical and or surgical intervention was provided to address the issue? please describe how was 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, age or date of birth; bmi patient pre-existing medical conditions (ie.Allergies, history of reactions).Does the patient use or 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? current patient status.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.

• 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
• MDR Report Key: 10854460
• MDR Text Key: 216766350
• Report Number: 2210968-2020-09092
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

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: 10/23/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 11/23/2020
• Supplement Dates FDA Received: 12/11/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention