MAUDE Adverse Event Report: DEROYAL INTERCONTINENTAL, S.R.L ABDOMINAL BINDER; BINDER, ABDOMINAL

Model Number	13652067
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Rash (2033)
Date of Event	09/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient developed a rash.Patient discontinued the use of the binder, but rash did spread.
Additional Manufacturer Narrative
A complaint was received on (b)(6) 2023 reporting the patient developed a rash.Patient discontinued the use of the binder, but rash did spread.The patient stated they have allergies to certain products but did not want to specify.This investigation is ongoing at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.
Additional Manufacturer Narrative
A complaint was received on 9/21/2023 reporting the patient developed a rash.Patient discontinued the use of the binder, but rash did spread.The patient stated they have allergies to certain products but did not want to specify.The sample was not returned to deroyal for evaluation.Deroyal was unable to determine the true root cause.Due to the root cause finding there were no corrective and or preventive actions taken.Product labeling was reviewed, and no issues related to latex were found.Production records were reviewed, and no issues were found.A total of 50 of the 13652067 binders were inspected by deroyal, and no discrepancies were identified during each inspection.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: ABDOMINAL BINDER
• Common Device Name: BINDER, ABDOMINAL
• Manufacturer (Section D): DEROYAL INTERCONTINENTAL, S.R.L; km 7 autopista joaquin balague; pisano free zone bldg 49; santiago, ; DR
• Manufacturer (Section G): DEROYAL INTERCONTINENTAL, S.R.L; km 7 autopista joaquin balague; pisano free zone bldg 49; santiago, ; DR
• Manufacturer Contact: melissa logsdon ; 200 debusk lane; powell, TN 37849 ; 8653626157
• MDR Report Key: 17923910
• Report Number: 3004605321-2023-00002
• Device Sequence Number: 11506026
• Product Code: FSD
• UDI-Device Identifier: 00749756283236
• UDI-Public: 00749756283236
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2023

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
• Device Model Number: 13652067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown