MAUDE Adverse Event Report: FHC, INC. MICROTARGETING¿ STERILE DRAPE SLEEVE; PATIENT SURGICAL DRAPE, SINGLE-USE

Model Number	66-DA-SD-00436
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	05/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Fhc is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by fhc, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Fhc has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, fhc, or its employees that the device, fhc or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Fhc objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Event or Problem Description
On (b)(6) 2025 fhc opened a record in our qms system regarding a product return issue from chile.During investigation into this issue, fhc discovered that our sales reps.In latin america had removed products from one distributor in chile and provided to a different customer in chile.Some of the products removed and redistributed were sterile.As per our qms procedures, products are to be returned to our headquarters (me, usa) for reinspection prior to any additional distribution activities.Some of the products redistributed were used in surgeries.There were no adverse events as a result of use.This report is being generated as there was a potential of risk since the product was not reinspected, sterility could have been compromised and could have resulted in an infection.

• Brand Name: MICROTARGETING¿ STERILE DRAPE SLEEVE
• Common Device Name: PATIENT SURGICAL DRAPE, SINGLE-USE
• Manufacturer (Section D): FHC, INC.; 1201 main street; bowdoin ME 04287
• Manufacturer (Section G): FHC, INC.; 1201 main street; bowdoin ME 04287
• Manufacturer Contact: kelly moeykens ; 1201 main street; bowdoin, ME 04087 ; 2076665651
• MDR Report Key: 22185419
• Report Number: 3002250546-2025-00003
• Device Sequence Number: 8356200
• Product Code: HAW
• UDI-Device Identifier: 00873263004364
• UDI-Public: 00873263004364
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K011992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 06/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 66-DA-SD-00436
• Device Catalogue Number: 66-DA-SD
• Device Lot Number: 274478
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown