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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Itching Sensation (1943); Skin Discoloration (2074); Blister (4537)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4). If it is reported that the device will not be returned at this time/not available: the following information has been requested however not received. To date the device has not been received. If the further details are received at a later date a supplemental medwatch will be sent. Date of reaction? is a photo available of the reaction? please detail dosage of medications, medrol prescribed. Please describe how the adhesive was applied. 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? is the patient hypersensitive to pressure sensitive adhesives? were any patch or sensitivity tests performed? patient demographics: initials / id, gender, age or date of birth; bmi. Patient pre-existing medical conditions (ie. Allergies, history of reactions). Has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? can you identify the lot number and/or product code that was used? what is the current status of the patient? is there any planned procedure/intervention to address the skin discoloration of incision? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported a patient underwent a thighplasty on (b)(6) 2020 and topical skin adhesive with mesh was used. Post op, when patient woke up from surgery both sides of leg were blistered. Discharged the next day. On day five symptoms: itchy, raised, red, and hot. On day six physician treated with benadryl and hydroxyzine. Adhesive was removed and went on a medrol taper. The itching and discoloration are gone but the incision line has not improved. Additional information has been requested.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 11243638
• MDR Text Key: 232575693
• Report Number: 2210968-2021-00760
• 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: consumer

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/05/2021
• 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

Patient Treatment Data

Date Received: 01/28/2021 Patient Sequence Number: 1