MAUDE Adverse Event Report: FCI SAS PTOSIS SLING; CRUTCH, PTOSIS

Model Number S3.1000U

Device Problems Break (1069); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2021

Event Type  malfunction  

Event Description

A box of 3 was purchased.The first sling was bent and unusable.The second sling was opened and broke during insertion: this one had patient contact but no patient harm.The third sling was able to be placed.Manufacturer response for ptosis sling set, (brand not provided) (per site reporter).They will send return kit and issue credit.

• Brand Name: PTOSIS SLING
• Type of Device: CRUTCH, PTOSIS
• Manufacturer (Section D): FCI SAS; 3308 jefferson ave; cincinnati OH 45220
• MDR Report Key: 12744788
• MDR Text Key: 279829162
• Report Number: 12744788
• Device Sequence Number: 1
• Product Code: HJZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S3.1000U
• Device Catalogue Number: S3.1000U
• Device Lot Number: 2055743
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/05/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22995 DA