MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH SCRO ZERO ANG 22CM; PENILE PROSTHESIS

Model Number ES29222400

Device Problems Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993); Pumping Problem (3016)

Patient Problems Unspecified Infection (1930); No Information (3190)

Event Date 08/12/2019

Event Type  Injury  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report 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, the device was explanted due to infection.

Manufacturer Narrative

This follow-up mdr is created to document the conclusion of the evaluation, additional device and implant date.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 non-conformances for this lot.No capas are associated with this lot.

Manufacturer Narrative

This follow-up mdr is created to document the conclusion of the investigation and note that 2125050-2019-00856-001 was submitted with the incorrect information please disregard.Patient id for 2125050-2019-00856 correlates with pt id (b)(6).Only update is culture results.The device was not received for evaluation.As examination of the device may not conclusively confirm or disprove the report of infection 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 revealed no trends for this lot.Review of nonconforming reports revealed no nonconformances for this lot.No capas are associated with this lot.

Manufacturer Narrative

This follow-up mdr is created to document the device return and conclusion of the investigation.Two malleable rods were received for evaluation.As examination of the device may not conclusively confirm or disprove the report of infection 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 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 TOUCH SCRO ZERO ANG 22CM
• Type of Device: PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9181809
• MDR Text Key: 162446564
• Report Number: 2125050-2019-00856
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• PMA/PMN Number: K040959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/12/2020

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: ES29222400
• Device Catalogue Number: ES2922
• Device Lot Number: 5120931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Initial Date Manufacturer Received: 09/12/2019
• Initial Date FDA Received: 10/11/2019
• Supplement Dates Manufacturer Received: 09/12/2019; 09/12/2019; 09/12/2019
• Supplement Dates FDA Received: 12/04/2019; 12/04/2019; 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR