MAUDE Adverse Event Report: COLOPLAST A/S TITAN RES ECLD 75CC; INFLATABLE PENILE PROSTHESIS

Model Number ER80752400

Device Problems Positioning Problem (3009); Migration (4003)

Patient Problem No Information (3190)

Event Date 09/23/2019

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.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, the reservoir migrated due to what seemed to be placement issue.Physician decided to use a new reservoir and place it in a different area.It was reported the reservoir was not defective.

Manufacturer Narrative

This follow-up mdr is created to document the conclusion of the evaluation, updated device information and implant date.The reservoir was discarded at surgery.As examination of the components may not conclusively confirm or disprove the report of migration, quality accepts the physician's observations as to the reason for surgical intervention.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, non-conformance's and capas revealed no trends for this lot.

• Brand Name: TITAN RES ECLD 75CC
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9227748
• MDR Text Key: 163707214
• Report Number: 2125050-2019-00907
• 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
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ER80752400
• Device Catalogue Number: ER8075
• Device Lot Number: 6565078
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR