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	11/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A complaint was received on (b)(6) 2023 reporting several female patients broke out in a rash across the area where the binder was on their skin.Used in labor and delivery post c section.A representative sample of the product was returned to deroyal for evaluation.A supplier corrective action request (scar) was issued to the raw material supplier north east knitting.The supplier stated all internal required process controls were followed.There have been no changes in their manufacturing process and or raw materials.Deroyal was unable to determine the true root cause.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.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.
Event or Problem Description
Several female patients broke out in a rash across the area where the binder was on their skin.Used in labor and delivery post c section.

• 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: 18310541
• Report Number: 3010452421-2023-00009
• Device Sequence Number: 6278106
• Product Code: FSD
• UDI-Device Identifier: 00749756283281
• UDI-Public: 00749756283281
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2023

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: 55074867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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