MAUDE Adverse Event Report: ORTHO & SURGICAL PRODUCTS ENTERPRISES S.A. ABDOMINAL BINDER, 9IN, 3-PANEL, 30-45IN, S/M; BINDER, ABDOMINAL

Model Number	13661056
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Rash (2033)
Date of Event	02/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint was received on (b)(6) 2024 reporting customer states she has hives underneath under breast and on back.Customer taking benadryl for reaction.A sample is not available to be returned to deroyal for evaluation.A supplier corrective action request (scar) was issued to the raw material supplier (b)(4).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
Customer states she has hives underneath under breast and on back.
Additional Manufacturer Narrative
A complaint was received on (b)(6) 2024 reporting customer states she has hives underneath under breast and on back where binder was worn.Customer taking benadryl for reaction.A sample was not available to be returned to deroyal.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 made to the raw material.The 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.Deroyal has previously completed biocompatibility on a similar device that uses these materials that was established that these materials are safe to use in contact with skin.A person may have a unique allergy, but the risk is remote.Product labeling was reviewed, and the appropriate symbols are present correctly indicating that the device is not made with natural rubber latex.Production records were reviewed, and no issues were found.A total of 50 of product number 13661056 lot 60424243 of the abdominal binders were randomly inspected by deroyal, and no discrepancies were identified during the 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, 9IN, 3-PANEL, 30-45IN, S/M
• 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: 18886344
• Report Number: 3010452421-2024-00002
• Device Sequence Number: 18027273
• Product Code: FSD
• UDI-Device Identifier: 00749756283274
• UDI-Public: 00749756283274
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2024

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: 13661056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/23/2024
• Supplement Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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