MAUDE Adverse Event Report: ORTHO & SURGICAL PRODUCTS ENTERPRISES S.A. ELBOW POSITIONER, IMMOBILIZER, BLUE PURR FOAM, W/METAL STAYS; RESTRAINT, PROTECTIVE

Model Number	M7035-S
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, "this patient had welcome sleeves on for iv protection.During a reposition, this rn noted that the metal bar had punctured through the welcome sleeve.Welcome sleeve was thrown away, skin check completed with no signs of injury at this time and a new welcome sleeve was placed." deroyal industries, inc.Requested return of the device but it was noted as not available for return.This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report when additional information becomes available.
Event or Problem Description
A user facility reported, "this patient had welcome sleeves on for iv protection.During a reposition, this rn noted that the metal bar had punctured through the welcome sleeve.Welcome sleeve was thrown away, skin check completed with no signs of injury at this time and a new welcome sleeve was placed.".
Additional Manufacturer Narrative
A user facility reported, "this patient had welcome sleeves on for iv protection.During a reposition, this rn noted that the metal bar had punctured through the welcome sleeve.Welcome sleeve was thrown away, skin check completed with no signs of injury at this time and a new welcome sleeve was placed." deroyal industries, inc.Requested return of the device but it was noted as not available for return.No pictures were available so condition of the product was unable to be confirmed.The device history record (dhr) and process records were reviewed and no issues were found during the review.Quality control inspections on 32 pairs were made over the lot under reference and no issues were found.An inventory check was also performed on 60 pairs and no issues were observed.The risk analysis was reviewed and found to be up to date.No updates were required.A complaint to sales ratio was conducted over the past two years and found to be (b)(4)%.Root cause: because the sample was unable to be returned and no issues were identified within the production records, no root cause could be determined.Corrective and preventive actions: because the root cause was unable to be determined, no corrective or preventive actions were taken.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: ELBOW POSITIONER, IMMOBILIZER, BLUE PURR FOAM, W/METAL STAYS
• Common Device Name: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): ORTHO & SURGICAL PRODUCTS ENTERPRISES S.A.; km 20.5 carretera a villa; zona 3 finca; morancito, villa canales 01065 ; GT 01065
• Manufacturer (Section G): ORTHO & SURGICAL PRODUCTS ENTERPRISES S.A.; km 20.5 carretera a villa; zona 3 finca; morancito, villa canales 01065 ; GT 01065
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 23815361
• Report Number: 3010452421-2025-00002
• Device Sequence Number: 13252681
• Product Code: FMQ
• UDI-Device Identifier: 00749756113427
• UDI-Public: 00749756113427
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M7035-S
• Device Lot Number: 62098955
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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