MAUDE Adverse Event Report: ORTHO & SURGICAL PRODUCTS ENTERPRISES S.A. ABDOMINAL BINDER; BINDER, ABDOMINAL

Model Number	13662067
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Rash (2033)
Date of Event	09/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint was received on (b)(6) 2023 reporting patient complained of a rash located where the abdominal binder was located.For this patient, use of the abdominal binder was immediately discontinued, resulting in the rash resolving shortly.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.
Event or Problem Description
Patient complained of a rash located where the abdominal binder was located.For this patient, use of the abdominal binder was immediately discontinued, resulting in the rash resolving shortly.
Additional Manufacturer Narrative
A complaint was received on 9/15/2023 reporting patient complained of a rash located where the abdominal binder was located.For this patient, use of the abdominal binder was immediately discontinued, resulting in the rash resolving shortly.The actual sample was not returned to deroyal for evaluation.Therefore, a true root cause was unable to be determined.Due to the root cause finding there were no corrective and or preventive actions taken.There have been no changes made to the raw material used for this abdominal binder.Product labeling was reviewed, and no issues related to latex were found.Production records were reviewed, and no issues were found.A work in process checks and an inventory check of the abdominal binder was made by deroyal, a total of 50 each of the 13662067 were inspected, and no discrepancies were identified during each inspection.Between july 1, 2021 - october 16, 2023, there have been a total of five complaints reported for this abdominal binder.Only two were related to rash and (b)(6) units sold for a percentage of 0.003%.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): ORTHO & SURGICAL PRODUCTS ENTERPRISES S.A.; km 20.5 carretera a villa; canales zona 3 finca morancito; villa canales, 01065, guatemala ; GT
• Manufacturer (Section G): ORTHO & SURGICAL PRODUCTS ENTERPRISES S.A.; km 20.5 carretera a villa; canales zona 3 finca morancito; villa canales, 01065, guatemala ; GT
• Manufacturer Contact: melissa logsdon ; 200 debusk lane; powell, TN 37849 ; 8653626157
• MDR Report Key: 17896450
• Report Number: 3010452421-2023-00003
• Device Sequence Number: 3454369
• Product Code: FSD
• UDI-Device Identifier: 00749756283281
• UDI-Public: 00749756283281
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2023

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: 13662067
• Device Lot Number: 59525733
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 10/18/2023
• 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