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 Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Local Reaction (2035)

Event Date 05/15/2021

Event Type  Injury  

Manufacturer Narrative

(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 obtain consent and provide photos. Please clarify the extent of the patient¿s skin reaction. What was the date of the reaction or day post op? what other medical and or surgical intervention was provided to address the issue? please describe how was 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? if yes, results available? patient demographics: id, age or date of birth; bmi has the patient previously been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? current patient status. No product is available for return.

Event Description

It was reported a patient underwent a total knee replacement on (b)(6) 2021 and topical skin adhesive was used. The patient had a severe allergic reaction including redness up to the back of ears post operatively. The removal of dressing and fexofenadine after first few days of piriton to alleviate itching. However then erythema spread, dressing was removed and fexofenadine given and good relief. 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: 12477724
• MDR Text Key: 271583990
• Report Number: 2210968-2021-08474
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• 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: 10/01/2021
• 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: 09/15/2021 Patient Sequence Number: 1