MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE Y CONTOUR; SURGICAL MESH

Model Number 5015202400

Device Problems Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to available information, the patient with this device required a revision that is planned in the near future.The physician recently had failure with a surgical mesh.It is unclear how or where the product failed.However, she suspects the sacral tail became detached.

Event Description

Additional information received further reported that revision surgery occurred (b)(6) 2021, and it was confirmed that the restorelle did detach from the sacrum.The physician was able to salvage enough tail to reattach and ¿hope for the best.¿.

• Brand Name: RESTORELLE Y CONTOUR
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11943975
• MDR Text Key: 254518273
• Report Number: 2125050-2021-00675
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• PMA/PMN Number: K140116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/09/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 5015202400
• Device Catalogue Number: 501520
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/06/2021
• Initial Date FDA Received: 06/05/2021
• Supplement Dates Manufacturer Received: 07/13/2021
• Supplement Dates FDA Received: 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention