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 09/14/2023

Event Type  malfunction  

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 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.

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
• 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: 17896450
• MDR Text Key: 326160949
• Report Number: 3010452421-2023-00003
• 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: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 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
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 10/09/2023
• Supplement Dates Manufacturer Received: 09/15/2023
• Supplement Dates FDA Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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