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

Catalog Number CLR602

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Erythema (1840); Itching Sensation (1943); Pain (1994); Rash (2033); Swelling (2091); Reaction (2414); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: procedure name and procedure date? location and incision size of product application? what prep was used prior to prineo use? was the prep allowed to dry prior to prineo mesh application? please describe how the adhesive was applied on the tape? when applying are they completely covering the edge of the mesh with prineo? was the mesh placed over the entire length of the incision? did the prineo mesh extend beyond the patient incision? was incision re-prepped before closure? if so, with what? if so, was the prep allowed to dry? was the skin prep solution wiped off and allowed to dry before applying adhesive? was a dressing placed over the incision? if so, what type of cover dressing used? date of reaction.What does the reaction look like? please provide details.How large of an area does the reaction cover? did the skin reaction extend beyond the borders of the tape? do you have any pictures of the reaction? what was done to address the reaction? what type of medication? dose? when (date) administered? was the product removed? was another method used to close the incision? was the site cultured? if so, what bacteria were identified? 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? what is the physicians opinion of the contributing factors to the reaction? what is the most current patient status? is the product or representative sample (product from the same lot number) available for evaluation? for female patients : was the patient exposed to similar products, such as artificial nails? was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? - pt underwent her first abdominoplasty in (b)(6) 2015.Not known if prineo was used on this occasion (operation note only says that the wound was closed with glue).Pt underwent revision surgery to revise the scar and to treat a lump on one side on (b)(6) 2016.The wound extended from hip to hip and was closed with prineo.The patient was discharged home and was reviewed in clinic 1 week post op.At this time her wound had an itchy, red rash extending the length of the wound and approximately 2cm above and below.There were no signs of infection, the wound remained intact and the patient was clinically otherwise well.The prineo was still attached and it was removed and not replaced.On (b)(6) the patient returned to clinic as the itchiness had become unbearable, and she was admitted to hospital and treated with antihistamines, prednisolone and fucidin cream.A wound swab was taken with no organisms grown.Following this treatment and an overnight stay, symptoms were brought under control and the pt was discharged home.She seems to be making a good recovery and is due to be reviewed in clinic again later this week.

Event Description

It was reported that the patient underwent a scar revision procedure and to treat a lump on one side on (b)(6) 2016 and a topical skin adhesive was used to close the wound, which was extended from hip to hip.The patient was advised to use octemisan as a lotion/shower gel before and after surgery.The patient was discharged home and was reviewed in clinic one week post op.At that time the patient experienced a pain, severe reaction and swelling, and was developing an itchy and red rash extending the length of the wound and approximately two centimeters above and below.There were no signs of infection, the wound remained intact and the patient was clinically otherwise well.The topical skin adhesive was removed and not replaced.On (b)(6) 2016, the patient returned to clinic as the itchiness had become unbearable, and she was admitted to hospital and treated with antihistamines, prednisolone and fucidin cream.A wound swab was taken with no organisms grown.Following this treatment and an overnight stay, symptoms were brought under control and the patient was discharged home.It was also reported that the patient seems to be making a good recovery and is due to be reviewed in clinic again later this week.

Manufacturer Narrative

Date sent to fda: 11/7/2016.Additional information: pt identifier, other relevant history.Additional information was requested and the following was obtained: (b)(6).Procedure name ¿ abdominoplasty scar revision & liposuction.Original abdominoplasty (b)(6) 2015 prineo tape used.Procedure date- (b)(6) 2016.Location and incision size of product application? abdomen.What prep was used prior to prineo use? aqueous betadine.Was the prep allowed to dry prior to prineo mesh application? yes.Please describe how the adhesive was applied on the tape? in accordance to protocol.When applying are they completely covering the edge of the mesh with prineo? yes.Was the mesh placed over the entire length of the incision? yes.Did the prineo mesh extend beyond the patient incision? yes.Was incision re-prepped before closure? if so, with what? if so, was the prep allowed to dry? yes, savalon.Was the skin prep solution wiped off and allowed to dry before applying adhesive? yes.Was a dressing placed over the incision? if so, what type of cover dressing used? gauze.Date of reaction ¿ on (b)(6) 2016.What does the reaction look like? please provide details ¿ red rash/blisters along scar line above & below prineo tape.How large of an area does the reaction cover? whole scar line plus above & below.Did the skin reaction extend beyond the borders of the tape - yes.Do you have any pictures of the reaction? yes.What was done to address the reaction? on (b)(6) 2016 started fexofenadine hc cream, hospital re-admission on (b)(6) 2016 octanisan stopped overnight for observation.What type of medication? dose? when (date) administered? predisone 40 mg od.Was the product removed? was another method used to close the incision? yes removed.No other closure.Was the site cultured? if so, what bacteria were identified? yes, normal skin flora.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? no allergies known.Is the patient hypersensitive to pressure sensitive adhesives? no.Were any patch or sensitivity tests performed? no.What is the physicians opinion of the contributing factors to the reaction? prineo tape.What is the most current patient status? all settled down.Is the product or representative sample (product from the same lot number) available for evaluation? given to company representative.Patient demographics: initials / id; age or date of birth; bmi ; gender ¿ (b)(6) female.Patient pre-existing medical conditions (ie.Allergies, history of reactions)- nil.For female patients : was the patient exposed to similar products, such as artificial nails- unknown.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? yes prineo on original abdominoplasty on (b)(6) 2015.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR 00754
• Manufacturer Contact: kenneth clark ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183547
• MDR Report Key: 5831537
• MDR Text Key: 50715112
• Report Number: 2210968-2016-10870
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/11/2016

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
• Device Expiration Date: 01/11/2018
• Device Catalogue Number: CLR602
• Device Lot Number: KBJ862
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/08/2016
• Initial Date FDA Received: 07/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/25/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 28 YR
• Patient Weight: 54