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

Catalog Number CLR602

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); No Code Available (3191)

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: 1. What is the procedure name and initial procedure date? -ulna nerve decompression and translocation - (b)(6) 2017. 2. What date did the reaction occur on? -within first 3-5 days. 3. What does the reaction look like and how large of an area does the reaction cover? -please see picture - it was swollen, red and bubbly - blisters. 4. Do you have any pictures of the reaction? -yes. 5. Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify. -silver nitrate cream and hydrocortisone cream. 6. What is the most current patient status? -patient says that area of incision or operation site is very sensitive still. 7. Can you identify the product code and lot number of the product that was used? -prineo - code not known, lot unknown.

Event Description

It was reported that a patient underwent a post-ulnar nerve decompression and translocation procedure on an (b)(6) 2017 and topical skin adhesive was used. Within 3-5 days post operatively, the patient experienced an allergic reaction to the topical skin adhesive. The patient was treated with silver nitrate cream and hydrocortisone cream. The area of the incision or operation site remains very sensitive. Additional information has been requested.

• 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: 8124762
• MDR Text Key: 129065445
• Report Number: 2210968-2018-77448
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• 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: 11/15/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: CLR602
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/15/2018
• 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?

• Type of Device Usage: Initial