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

Model Number 13662067

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Rash (2033)

Event Date 11/15/2023

Event Type  Injury  

Manufacturer Narrative

A complaint was received on 11/15/2023 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.A total of 50 samples were randomly 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.

Event 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
• Type of Device: 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: 18310577
• MDR Text Key: 330281288
• Report Number: 3010452421-2023-00014
• Device Sequence Number: 1
• Product Code: FSD
• UDI-Device Identifier: 00749756283281
• UDI-Public: 00749756283281
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1