MAUDE Adverse Event Report: COLOPLAST A/S TITAN SCROTAL ZERO ANG 20CM; INFLATABLE PENILE PROSTHESIS

Model Number ES89202400

Device Problems Break (1069); Fracture (1260); Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 10/31/2019

Event Type  Injury  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming reports and capa review.No trends were noted.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 the available information, leak was reported.No fluid in device, tubing fracture to pump was noted.Another inflatable device was implanted.

Manufacturer Narrative

This follow-up was created to document the corrected device codes and conclusion of the investigation.The device was not received for evaluation.Without the benefit of analyzing the device quality cannot confirm any observations or comment on the condition of the product.If the device become available, or additional information is received, the complaint will be re-evaluated according to procedures.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database revealed no trends for this lot.Review of nonconforming reports revealed no nonconformances for this lot.No capas are associated with this lot.

• Brand Name: TITAN SCROTAL ZERO ANG 20CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9644066
• MDR Text Key: 176865993
• Report Number: 2125050-2020-00074
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932487368
• UDI-Public: 05708932487368
• 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: 03/06/2020

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: ES89202400
• Device Catalogue Number: ES8920
• Device Lot Number: 3787514
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/30/2019
• Initial Date FDA Received: 01/29/2020
• Supplement Dates Manufacturer Received: 12/30/2019
• Supplement Dates FDA Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR