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 Skin Irritation (2076); Not Applicable (3189)

Event Date 06/09/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Attempts to obtain the following information have been made, however not received to date.Attempts have also been made to obtain the device.To date the device has not been returned.If further details are received at a later date a supplemental medwatch will be sent.Name of procedure? date of procedure? date of reaction? was there any treatment provided (reoperation; reclosure; prescriptions; antibiotics prescribed) to address reaction? if so, please provide details.Please indicate any medical or surgical interventions performed.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? did the patient have prior experience with dermabond and this surgical glue in a prior procedure? 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).Current patient condition? 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.Note: events reported via mw# 2210968-2020-04931, mw# 2210968-2020-04933, mw# 2210968-2020-04934.

Event Description

It was reported a patient underwent an unknown procedure on an unknown date in 2020 and a topical skin adhesive/sealant was used.The patient experienced a reaction.The patient was going to be readmitted and consult from a dermatologist is being requested.The reaction was where the glue went beyond the tape.Additional information has been requested.

Manufacturer Narrative

Product complaint#: (b)(4).Date sent to the fda: 8/5/2020.Attempts have been made to obtain the following information but have not been received.The device has not been received.If further details are received at a later date a supplemental medwatch will be sent.It was noted that immediate removal of prineo device from 4 port sites whilst still in the hospitals care.Please advise what was used in place of prineo to close the wounds? were any other medications/treatment provided? please provide details.Were any other surgical intervention provided? please provide details.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: 7/7/2020.The following information was requested and no response has been received.To date the device has not been returned.If further details are received at a later date a supplemental medwatch will be sent.Name of procedure? laparoscopic sleeve gastrectomy.Date of procedure? (b)(6) 2020.Date of reaction? (b)(6) 2020.Was there any treatment provided (reoperation; reclosure; prescriptions; antibiotics prescribed) to address reaction? if so, please provide details.Immediate removal of prineo device from 4 port sites whilst still in the hospitals care.Please indicate any medical or surgical interventions performed.Surgeon suggested that the patients reaction became continued to worsen after discharge.Please describe how was the adhesive was applied.As per the ifu, surgeon and assistant have been using prineo successfully over 18 months and more than 200 patients.What prep was used prior to, during or after prineo use? unknown, surgeon ¿just uses what is given to him.¿ was a dressing placed over the incision? if so, what type of cover dressing used? no dressings used over the prineo.Did the patient have prior experience with dermabond and this surgical glue in a prior procedure? no prior exposure to dermabond or prineo known.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? not known.Is the patient hypersensitive to pressure sensitive adhesives? post reaction cconversation with the patient the patient has said that she ¿sometimes gets dermititis.Were any patch or sensitivity tests performed? not know, however patient was readmitted to hospital under a dermatologist.Patient demographics: initials / id; age or date of birth; bmi ; (no information).Patient pre-existing medical conditions (ie.Allergies, history of reactions).Dermititis not disclosed to the surgeon prior to procedure.Does the patient use or exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails).Unknown.Current patient condition? surgeon has not had contact with the patient this week and will update once he sees her at follow up appointment in (b)(6).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: (b)(6) 2020.Attempts have been made to obtain the following information but have not been received.The device has not been received.If further details are received at a later date a supplemental medwatch will be sent.It was noted that immediate removal of prineo device from 4 port sites whilst still in the hospitals care.Please advise what was used in place of prineo to close the wounds? were any other medications/treatment provided? please provide details.Were any other surgical intervention provided? please provide details.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: 10210022
• MDR Text Key: 197161431
• Report Number: 2210968-2020-04932
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• 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: 07/08/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention