MAUDE Adverse Event Report: ORTHO AND SURGICAL PRODUCTS ENTERPRISES S.A. DEROYAL; LIMB HOLDER

Model Number NOT PROVIDED

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 09/05/2019

Event Type  Injury  

Manufacturer Narrative

Gwtest connecttest mlogsdon (b)(6) 2020.

Event Description

Gwtest connecttest.

Manufacturer Narrative

Gwtest mlogsdon (b)(6) 2021.

Event Description

Gwtest.

Manufacturer Narrative

Gwtest mlogsd on (b)(6) 2021.

Event Description

Gwtest.

Manufacturer Narrative

(b)(4) 2/3/2023.

Event Description

Gwtest - new signing certificate.

• Brand Name: DEROYAL
• Type of Device: LIMB HOLDER
• Manufacturer (Section D): ORTHO AND SURGICAL PRODUCTS ENTERPRISES S.A.; km 20.5 carretera a; villa canales; villa canales, 01065 ; GT 01065
• Manufacturer (Section G): ORTHO AND SURGICAL PRODUCTS ENTERPRISES S.A.; km 20.5 carretera a; villa canales; villa canales, 01065 ; GT 01065
• Manufacturer Contact: melissa logsdon ; 200 debusk lane; powell 37849 ; 3626157
• MDR Report Key: 10205516
• MDR Text Key: 199531703
• Report Number: 3010452421-2020-00003
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention