MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE; CUTANEOUS TISSUE ADHESIVE WITH MESH

Catalog Number CLR422

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Skin Inflammation/ Irritation (4545)

Event Date 12/11/2021

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.(b)(4) patient 2 id: ct female (b)(6) nkallergies.Daa hip arthroplasty on (b)(6) 2021, reaction- (b)(6) 2021 (10), photo, dressing: ch - to company directions.Surgical prep:chlorhexidine 2% (red), dressing-no, nk allergies, yes sensitivity to adhesive, no patch tests, yes had previous exposure, yes used prineo/db, recovered.A manufacturing record evaluation was performed for the finished device batch and no non-conformances were identified.No product available for return.

Event Description

It was reported a patient underwent a hip arthroplasty on (b)(6) 2021 and topical skin adhesive was used.Patient had an allergic reaction to adhesive.Patient had reaction on (b)(6) 2021, post op day 10, and put on oral corticosteroids to manage the severe allergic reaction.Wounds not infected highly irritated rash associated with the dressing.Additional information has been requested.

• Brand Name: DERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE
• Type of Device: CUTANEOUS TISSUE ADHESIVE WITH MESH
• 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 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13497511
• MDR Text Key: 289316144
• Report Number: 2210968-2022-00929
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K163645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: CLR422
• Device Lot Number: RHBCKT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female