MAUDE Adverse Event Report: COLOPLAST A/S PUMP; INFLATABLE PENILE PROSTHESIS

Model Number 5177701400

Device Problem Material Rupture (1546)

Patient Problem No Information (3190)

Event Date 10/04/2018

Event Type  Injury  

Manufacturer Narrative

The device has been received at coloplast; however the evaluation is not yet complete.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.

Event Description

According to the available information, the device was explanted because the ipp stopped inflating.Upon explant of the device, a break at the junction between release bars and bulb, as well as on the bulb itself, was detected.

Manufacturer Narrative

A titan pump was received for evaluation.Examination and testing of the returned component revealed a separation in the bulb of the pump.Testing revealed this to be a site of leakage.The separation appeared smooth and non-striated, indicating sufficient stress(s) was exerted to separate the site.A partial separation within abrasion was noted in the inlet tube of the pump.Testing revealed this not to be a site of leakage.Surface abrasion was noted in both exhaust tubes of the pump.Based on previous quality simulations and examination of the returned product, quality concluded that the smooth, dull and non-striated surfaces associated with this separation indicates that sufficient stress(s) was exerted on the bulb of the pump to separate the site while in-vivo.A separation of this type would then allow the loss of fluid, making the device inoperable.Quality reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.Review of nonconforming reports revealed no nonconformance with this lot that would have contributed to the event.A review of the complaint database revealed no significant trends in complaints of this type for lot 5887662.

• Brand Name: PUMP
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8025576
• MDR Text Key: 125695852
• Report Number: 2125050-2018-00782
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5177701400
• Device Catalogue Number: 517770
• Device Lot Number: 5887662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Date Manufacturer Received: 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR