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 Problem Blister (4537)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.What is the alleged reported issue for each of the sutures? lead to blistering (prineo) what tissue layer was each suture used to close? stratafix symmetric used on fascia, stratafix bidirectional used on subcuticular, dermabond prineo used on skin does the surgeon believe the suture had a causal impact on the blistering? yes is photo available of patient's blister? no please describe how was the adhesive was applied.Unknown.What prep was used prior to, during or after adhesive use? unknown other than patient roughly removed prineo on own was a dressing placed over the incision? if so, what type of cover dressing used? unknown.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unknown.Is the patient hypersensitive to pressure sensitive adhesives? unknown.Was patient screening done prior the procedure, e.G.Check patient not allergic to cyanoacrylate, formaldehyde, bac, pressure-sensitive adhesive? unknown.Patient demographics: initials / id, gender, age or date of birth; bmi unknown.Patient pre-existing medical conditions (ie.Allergies, history of reactions) unknown.Has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? unknown.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? unknown.Product code and/or lot of product used? unknown.Current patient status.Healing okay.What is the physician¿s opinion as to the etiology of or contributing factors to this event? unknown.No product is available for return.Note: events reported on mw# 2210968-2022-06758, mw# 2210968-2022-06759, mw# 2210968-2022-06761.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.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 right total knee replacement surgery on an unknown date in (b)(6) 2022 and suture was used.Post op, the patient presented with blistering.Date of blistering is unknown.On (b)(6) 2022, patient received incision and drainage.No further information was provided.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; road 183, km. 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15254442
• MDR Text Key: 298194485
• Report Number: 2210968-2022-06760
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2022
• 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