MAUDE Adverse Event Report: COLOPLAST A/S (OUT) TITAN OTR SCROTAL; INFLATABLE PENILE PROSTHESIS

Model Number QSR9181750

Device Problems Break (1069); Leak/Splash (1354); Material Rupture (1546)

Patient Problem No Information (3190)

Event Date 11/13/2018

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 had no fluid left in the system.A tear was found in the tubing under the cylinders when examined.

Manufacturer Narrative

This follow-up is created to document the device received, updated pt id, was (b)(6) not (b)(6), and update additional device code.The device has been received at coloplast; however the evaluation is not yet complete.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.

Manufacturer Narrative

This follow-up mdr is created to document the evaluation of the returned device.A titan otr pump and two cylinders were received for evaluation.Examination and testing of the returned components revealed a separation is noted in the longer exhaust tube of the pump.Testing revealed this to be a site of leakage.The separation appears to be rough and irregular, indicating sufficient stress was exerted.Surface abrasion is noted on all strain relief and all tubes of the pump and on the exhaust tube of cylinder #1.Partial separations within abrasion are noted on the shorter exhaust tube and the inlet tube of the pump.Testing revealed these not to be sites of leakage.No functional abnormalities are noted with cylinder #1 or cylinder #2.Based on previous quality simulations and examination of the returned product, quality concluded that the rough and irregular surfaces associated with this separation indicates that sufficient stress(s) was exerted on the longer exhaust tube of the pump to separate the site while in-vivo.A separation of this type would then allow the loss of fluid, making the device inoperable.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.A review of the complaint history database revealed no significant trends for lot 1759260.Review of nonconforming reports revealed no nonconformance's for this lot.No capas are associated with this lot.

• Brand Name: (OUT) TITAN OTR SCROTAL
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8157070
• MDR Text Key: 130162330
• Report Number: 2125050-2018-00875
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2019

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: QSR9181750
• Device Catalogue Number: QSR918
• Device Lot Number: 1759260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 12/12/2018
• Supplement Dates Manufacturer Received: 11/13/2018; 11/13/2018
• Supplement Dates FDA Received: 01/15/2019; 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR