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 Erythema (1840); Inflammation (1932); Reaction (2414); No Code Available (3191)

Event Date 02/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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: it was reported that the patient was treated with ointment and monitored.Was the ointment used on the patient prescribed? ¿yes.How was the device was used (what layer of tissue and how many layers applied)?.No information.What was the location and incision size of prineo application?.Prineo was applied on the wound closure of the epiderm after a caesarean section what prep was used prior to prineo application?.No information.Was the prep allowed to dry prior to prineo mesh application?.No information.Please describe how the adhesive was applied on the tape?.No information.Was the mesh placed over the entire length of the incision?.No information.Was the dermabond liquid adhesive placed to cover the entire length of the mesh? ¿no information.Did the prineo mesh extend beyond the patient incision? ¿no information.Was incision re-prepped before closure? ¿no information.If so, with what? if so, was the prep allowed to dry? was the skin prep solution wiped off and let dry before applying adhesive? ¿no information.Was a dressing placed over the incision? ¿no information.If so, what type of cover dressing used? do you have any pictures of the reaction?.No, we don¿t.What was done to address the reaction? ¿the affected site was treated with ointment.Were prescription steroids administered? ¿no information.If so, what type of medication was used to treat the reaction? what was the dosage? when (date) was the medication administered? were antibiotics prescribed? ¿no information.What type of medication was used to treat the reaction? what was the dosage? when (date) was the medication administered? was the blister drained or aspirated? ¿no information.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? ¿no information.Is the patient hypersensitive to pressure sensitive adhesives? ¿no information.Were any patch or sensitivity tests performed? ¿no information.Can you identify the lot number of the product that was used? ¿no information.What is the most current patient status? ¿she was in the hospital as of february 14.She was treated with ointment, and monitored.Was prineo previously used on the patient in a previous surgery? ¿no information.If yes what was the outcome of previous surgery?.

Event Description

It was reported that the patient underwent a c-section procedure on (b)(6) 2017 and the topical skin adhesive was used on the wound closure of the epidermis.Three days after the procedure, a reddish inflammatory skin reaction was observed on the area on which the topical skin adhesive was applied.The patient also experienced blistered epidermis and the topical skin adhesive was removed.The patient was in the hospital as of (b)(6) 2017, treated with prescribed ointment, and monitored.The doctor opined that there was a high possibility that the topical skin adhesive caused the reddish inflammatory skin reaction since it occurred only on the area on which the topical skin adhesive mesh was applied.The doctor also opined about another contributing factor that there was a risk of reddish inflammatory reaction originally due to the patient is prone to get a rash from the tape.

• 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: 6385274
• MDR Text Key: 69284867
• Report Number: 2210968-2017-31035
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133864
• 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
• Report Date: 02/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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