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

Catalog Number CLR602US

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Scarring (2061)

Event Type  Injury  

Manufacturer Narrative

(b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form. Additional information was requested and the following was obtained: do you have any photos? name of procedure? what is meant by permanent scarring? what date did the reaction occur post op? 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? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? were any patch or sensitivity tests performed? what is the physicians opinion of the contributing factors to the reaction? patient demographics: initials / id; age or date of birth; bmi ; gender. Patient pre-existing medical conditions (ie. Allergies, history of reactions). For female patients ask: 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? what is the most current patient status?.

Event Description

It was reported that the patient underwent a plastic surgery procedure on an unknown date and topical skin adhesive was used. The patient returned with an allergic reaction where the topical skin adhesive was applied. The doctor may have removed the topical skin adhesive and applied topical steroids. It is possible that the patient may have permanent scarring from the topical skin adhesive. Additional information has been requested.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM -US
• 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; road 183, km. 8.3; san lorenzo PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7596456
• MDR Text Key: 110911293
• Report Number: 2210968-2018-73446
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: CLR602US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/18/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/13/2018 Patient Sequence Number: 1