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 Rash (2033); Reaction (2414); No Code Available (3191)

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: what was the specific location of the rash on the body? all 4 patient had reactions inside of both arms and inner thighs, and some patients also had across waist at back.Does the reaction extend 1-2 inches beyond each tape or only 1 site of the tape? multiple areas.Rash was under arms, inner thighs, across back at waist.Rash was not systemic, rash was localized around tape.Were each of the 4 patients female and approximately 40 ¿ yes.Was the topical steroid cream prescribed or over the counter? treated with prescription topical steroids.Event dates: all 4 procedure dates were within the last quarter.No photos or patient demographic data is available.Please clarify "cut the skin away" mean - these are plastic surgery procedures.He uses a scalpel and scissors.The cases are big body lifts, removing a lot of skin.

Event Description

It was reported that the patient underwent a major body lift plastic procedure on unknown date and the topical skin adhesive was used.Following the procedure, the patient developed a rash and reaction was located inside of both arms and inner thighs, and/or across waist at back.Rash was not systemic but localized around tape.The patient was treated with prescription topical steroids.

• 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: 6373521
• MDR Text Key: 68854074
• Report Number: 2210968-2017-30966
• 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
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• 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: 02/08/2017
• 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
• Patient Age: 40 YR