MAUDE Adverse Event Report: COLOPLAST A/S TITAN RES ECLD 125CC; INFLATABLE PENILE PROSTHESIS

Model Number ER81252400

Device Problems Migration or Expulsion of Device (1395); Insufficient Information (3190)

Patient Problems Hernia (2240); Discomfort (2330)

Event Date 06/05/2018

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.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, exchanged reservoir due to hernia repair.

Event Description

According to the available information, exchanged reservoir due to hernia repair.Additional information received indicated the patient presented with diffuse abdominal discomfort and was found to have the penile implant reservoir residing intraperitoneally along the right gutter.On physical exam the patient had not pertinent findings and did not have a palpable hernia at the level of external inguinal ring where his reservoir had been previously introduced.The reservoir had migrated.

Manufacturer Narrative

Quality was unsuccessful in securing the explanted prosthesis for evaluation.Without the benefit of analyzing the explant, quality cannot confirm any observations and cannot comment on the condition of the prosthesis.If the explanted device becomes available, or additional information is received, quality will re-evaluate this complaint in accordance to procedures.However, because quality's examination may not conclusively confirm or disprove the report of a hernia, quality accepts the physician's observations of such as the reason for surgical intervention.Because identification numbers were not provided, quality was unable to trace device lot history of the device, complaint history, non-conformances, and capas for this lot number.However, all devices sold and labeled by this corporation must pass manufacturing, quality, and sterility procedures prior to release.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 RES ECLD 125CC
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7697768
• MDR Text Key: 114291219
• Report Number: 2125050-2018-00521
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932473927
• UDI-Public: 05708932473927
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/12/2018

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: ER81252400
• Device Catalogue Number: ER8125
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/20/2018
• Initial Date FDA Received: 07/18/2018
• Supplement Dates Manufacturer Received: 06/20/2018
• Supplement Dates FDA Received: 09/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR