MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE L; INFLATABLE PENILE PROSTHESIS

Model Number 5014502400

Device Problems Material Protrusion/Extrusion (2979); Appropriate Term/Code Not Available (3191)

Patient Problems Urinary Tract Infection (2120); Dysuria (2684); Dyspareunia (4505); Urinary Incontinence (4572)

Event Type  Injury  

Manufacturer Narrative

The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.

Event Description

As reported to coloplast, though not verified, the patient with this device experienced urinary tract infection, therefore, the competitor's devices were removed.He continued to have urinary frequency, change in urinary flow, change in urinary flow, the patient was urinating over her leg.Additionally, this patient continued to experience urinary incontinence, urinary frequency, urgency.A new coloplast device was implanted.Subsequently,.

Event Description

According to additional available information, the patient with this device experienced dyspareunia, stress urinary incontinence, recurrent urinary tract infections, cystocele with rectocele, vaginal mesh exposures, and severe atrophy.Partial excision of surgical mesh was performed along with anterior/posterior enterocele repair and vaginal colpopexy and cystoscopy.Surgical mesh exposures were located along the distal urethra midline and right vaginal sulcus.

• Brand Name: RESTORELLE L
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usjki jennifer kinneman ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 11786946
• MDR Text Key: 249492981
• Report Number: 2125050-2021-00473
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2015
• Device Model Number: 5014502400
• Device Catalogue Number: 501450
• Device Lot Number: 3057135
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/10/2022
• Date Device Manufactured: 02/13/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female