MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH SCRO ZERO ANG 16CM; INFLATABLE PENILE PROSTHESIS

Model Number ES29161022

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 04/24/2018

Event Type  Injury  

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.Once our evaluation is complete, a follow-up report will be submitted.

Event Description

According to the available information, the patient was unable to inflate the device.Once seen the device, it appeared that there was a complete fluid loss.This was due to a pin-prick hole on the cylinder.There appeared to be a bend in the device where the hole leaking fluid.There was a pin-prick hole in the cylinder where the device seemed to naturally bend.

Manufacturer Narrative

One cylinder was received for evaluation.A non-striated, dull, and smooth separation was noted in the bladder of cylinder 1 near the base.Testing revealed this to be a site of leakage.No bend in the cylinder was noted.Quality reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.Review of nonconforming reports revealed no nonconformance with this lot that would have contributed to the event.A review of the complaint database revealed no significant trends in complaints of this type for lot 5493085.Because these components were released according to manufacturing and quality control procedures, quality concluded that the observed separation in the bladder of cylinder 1 occurred subsequent to the device packaging being opened.Based on quality's examination, the reported "bend" in the cylinder where the leakage occurred was not confirmed.There was no evidence of crease points on the cylinder bladder.As the device was implanted approximately four years, and assumed functional during that time, quality is unable to determine when the separation occurred or the most probable root cause of the separation.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type are captured in the product risk documentation.Based on this information, no further corrective action is required at this time.

• Brand Name: TITAN TOUCH SCRO ZERO ANG 16CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7566481
• MDR Text Key: 109979307
• Report Number: 2125050-2018-00415
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ES29161022
• Device Catalogue Number: ES29161022
• Device Lot Number: 5493085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR