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 Itching Sensation (1943); Rash (2033); Unspecified Tissue Injury (4559)

Event Date 11/01/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4). Additional information has been requested however not received. If further details are received at a later date a supplemental medwatch will be sent. Please address the questions below to aide in our complaint investigation: what product code of prineo was used? lot number? are any photos of the patient reaction available? date of reaction? 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: age or date of birth; bmi patient pre-existing medical conditions (ie. Allergies, history of reactions)? has the patient previously been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? was prineo/dermabond skin adhesive used on the patient in a previous surgery or wound closure? no product to return. This medwatch report is in response to receipt of a voluntary medwatch: mw5101164.

Event Description

It was reported a patient underwent a subcutaneous mastectomy on (b)(6) 2020 and topical skin adhesive was used. On an unknown date in 2020, patient developed a papular, erythematous, pruritic rash that involved the entire extent of the wound. Because of persistent pruritus and resultant itching and scratching, the right nipple graft was displaced on postoperative day 12 (2020). The right nipple was sutured to the wound by surgeon, the day of the event, with preservation of vascular supply. The wounds healed well with no further complications. No device will be returned. Additional information has been requested.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12094942
• MDR Text Key: 264943607
• Report Number: 2210968-2021-05955
• 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: other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• 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: 07/14/2021
• 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: 06/30/2021 Patient Sequence Number: 1