MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE; SURGICAL SEALANT

Model Number CLR222

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

Patient Problem Insufficient Information (4580)

Event Date 04/25/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information: (b)(4).Additional information has been requested and received.Please clarify how was the dermabond prineo applied to the patient? ans:- after subcute layer closer, we applied dermabond prineo.Were there any patient consequences? ans:- dark stain on the dressing.Was there any medical or surgical intervention performed to treat the patient (product removed; re-operation; re-closure; prescription medication)? if so, please specify.Ans:- remove or antibiotic.If medication was required, please clarify if it was prescription strength.Ans:- levofloxacin.What is the most current patient status? ans:- all well.Is the device available to be returned for evaluation? ans:- no.If yes, what is the device return status? ans:- no.Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Name of surgery? what was the procedure date? what was the alleged deficiency with the prineo? was any surgical intervention performed? were antibiotics given prophylactically? were antibiotics given due to ¿dark stain¿ dust on prineo? did the dust penetrate the wound? were any cultures taken? provide results? please describe how was the adhesive was applied.What prep was used prior to, during or after adhesive use? was a dressing placed over the incision? if so, what type of cover dressing used? patient demographics: initials / id, gender, age or date of birth; bmi.Patient pre-existing medical conditions (ie.Allergies, history of reactions) current patient status.What is the physician¿s opinion as to the etiology of or contributing factors to this event? the lot provided is not valid: rbdvaa/ please verify the lot? no product is available for return.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 an unknown procedure on an unknown dat and topical skin adhesive was used.After applying adhesive dust and dirt accumulated on patient facing the side of the mesh.The adhesive was remove and given antibiotics- levofloxacin.Additional information has been requested.

• Brand Name: DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE
• 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 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15219811
• MDR Text Key: 297855895
• Report Number: 2210968-2022-06543
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031237339
• UDI-Public: 10705031237339
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CLR222
• Device Catalogue Number: CLR222
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/21/2022
• 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