MAUDE Adverse Event Report: COLOPLAST A/S TITAN INFRA ZERO ANG 18CM; INFLATABLE PENILE PROSTHESIS

Model Number ES88182400

Device Problems Inadequacy of Device Shape and/or Size (1583); Positioning Problem (3009)

Patient Problem No Information (3190)

Event Date 08/01/2019

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, there was a repositioning of the pump.Additional information received indicated there was a revision of the implant with replacement of implant pump.The pre-operative and post-operative diagnosis was listed as "malpositioned implant".During the revision procedure, it was noted that there was a high riding pump and one of the tubes was shorter than anticipated.

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 implanted on (b)(6) 2019.The patient had two in-office visits post implant on (b)(6) 2019 and (b)(6) 2019.On (b)(6) 2019 the pump was revised but remained implanted.It was reported the pump was riding high and one of the tubes was shorter than anticipated.

• Brand Name: TITAN INFRA ZERO ANG 18CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8972188
• MDR Text Key: 156822761
• Report Number: 2125050-2019-00723
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932319621
• UDI-Public: 05708932319621
• 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: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ES88182400
• Device Catalogue Number: ES8818
• Device Lot Number: 6625389
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR