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

Model Number ES88202400

Device Problems Crack (1135); Fracture (1260); Pumping Problem (3016)

Patient Problem No Information (3190)

Event Date 07/03/2019

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 pump was fractured.A new pump was implanted.

Manufacturer Narrative

This follow-up mdr is created to document the additional event information and the 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 becomes 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, non-conformances and capas revealed no trends for this lot.

Event Description

Additional information received indicated the device was not pumping.

Event Description

Additional information received.Pt reports the pump not working.The pump had a small crack at the bottom.Pump only removed, the cylinders and reservoir were left in place.

Manufacturer Narrative

This follow-up was created to document the additional event and patient information.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 becomes 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, non-conformances and capas revealed no trends for this lot.Uf/importer report # was reported to be 490043-2019-0003; however it is unclear if the report had already been sent to the fda by the user facility.

• Brand Name: TITAN INFRA ZERO ANG 20CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9298080
• MDR Text Key: 165653215
• Report Number: 2125050-2019-00958
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932487245
• UDI-Public: 05708932487245
• 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,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ES88202400
• Device Catalogue Number: ES8820
• Device Lot Number: 6401858
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 87