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

Catalog Number CLR222US

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Scarring (2061); Discharge (2225); Reaction (2414); No Code Available (3191)

Event Date 05/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: location and incision size of product application? ~ 6 cm: lateral side of the foot.What prep was used prior to prineo use? betadine prep.Please describe how the adhesive was applied on the tape? as per the product recommendations: spread out over the squares ~ 1/2 brush width outside of the mesh.Was incision re-prepped before closure? if so, with what? no.What was done to address the reaction? the reaction is still going on.Thus to date: medro dosepack, benadryl, betadine swabs to incision/open area bid, yesterday: keflex 500 tid and continued betadine swabs.What type of medication? dose? when (date) administered? see above.Date that the perineo was removed ? was another method used to close the incision? two weeks post op; at that appointment, benzoin and steri-strips were applied.No other method used to close the incision.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? no.Is the patient hypersensitive to pressure sensitive adhesives? no.Were any patch or sensitivity tests performed? no.Lot number involved unknown.What is the physicians opinion of the contributing factors to the reaction? unknown.What is the most current patient status? tbd.Recently placed on keflex.Wound still draining and not completely closed even though ~ 5 weeks post op.Is the product or representative sample (product from the same lot number) available for evaluation? no, discarded.Patient demographics: initials / id; bmi female, (b)(6) y/o.Thin.Female.Patient pre-existing medical conditions (ie.Allergies, history of reactions) none.Has patient been exposed to similar products, such as artificial nails - unknown.Other surgeries that perineo/demabond or skin adhesive was used on patient? patient had topical skin adhesive in (b)(6) 2016 with no adverse reaction.

Event Description

It was reported that a (b)(6) year old female patient underwent a hardware removal procedure of the right foot on (b)(6) 2017 and topical skin adhesive was used.In addition, 4 x 4's, kerlix and an ace wrap was placed on top of topical skin adhesive.On (b)(6) 2017 the patients mother reported that the patient had red bumps on her leg and was experiencing itching.A medrol dose pack was prescribed and calamine lotion.On (b)(6) 2017 the patient developed a maculopapular rash on the foot and the calcaneus with evidence of folliculitis.The patient was prescribed prednisone, zyrtec, and betadine swabs on her incision open area twice a day.The topical skin adhesive was removed two weeks post op.The incision was kept closed with steri-strips and benzoin was applied.On (b)(6) 2017 it was reported that the rash was improving.The patient has desquamation and scarring where the rash was.The pruritis was gone at this time.The patient has been recently placed on keflex and continues betadine swabs as the reaction is still ongoing.The wound is still draining and not completely closed even though approximately five weeks post op.Additional information has been requested.

Manufacturer Narrative

Additional information was requested and the following was obtained: what prep was used prior to prineo use? duraprep.Additional information: the pa reports they have now been starting to pull the prineo off at the two week period.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Was there any complaint regarding the prineo used during the first surgery (b)(6) 2016? the single complaint was reported with multiple events.There are no additional details regarding the additional events.Attempts are being made to obtain any additional patient events.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.

Manufacturer Narrative

Date sent to fda: 6/29/2017 additional information was requested and the following was obtained: was there any complaint regarding the prineo used during the first surgery (b)(6) 2016? there were no problems with the prineo after the (b)(6) 2016 surgery.

• 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: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6613653
• MDR Text Key: 76706836
• Report Number: 2210968-2017-32409
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention
• Patient Age: 17 YR