MAUDE Adverse Event Report: COLOPLAST A/S ALPHA I; PENILE PROSTHESIS

Model Number 5183301000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and 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 available information, the patient with this device experienced pain.It was reported that this device stopped working approximately three years ago due to an unspecified cause.

Manufacturer Narrative

Titan otr pump, cylinders 1 and 2, and reservoir were received for evaluation.A separation within abrasion was noted on the inlet tube of the pump.This was a site of leakage.Partial separations within abrasion were also noted on the inlet tube near the separation site.These were not sites of leakage.Partial separations within abrasion were noted on the exhaust tube of cylinder 2.This was not a site of leakage.No functional abnormalities were noted with cylinders 1 and 2.A partial separation was noted on the inlet tube near the tube/strain relief junction of the reservoir.This was not a site of leakage.No functional abnormalities were noted with the reservoir.Based on recreation of the position of the tubes according to the abrasion pattern, this demonstrates that the exhaust tube of cylinder 2 and inlet tube were overlapping while in vivo.This positioning, in combination with device usage over time, may contribute to sufficient stress(s) to separate the exhaust tubing of cylinder 2.A separation of this type could then allow the loss of fluid, making the device inoperable.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, nonconformances and capas revealed no trends for this lot.D4 lot: 1780100.

Event Description

According to the available information this inflatable penile prosthesis was implanted in 2012 and removed on (b)(6) 2020 due to a device malfunction, stopped working three years ago.Patient experienced pain and was not interested in having the device replaced.Additional information received with the operative report indicated the device stopped working approx.2 years ago.Op report notes the patient states the device is causing him significant discomfort over his suprapubic region and wishes to have it removed.

• Brand Name: ALPHA I
• Type of Device: PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 12464518
• MDR Text Key: 271215247
• Report Number: 2125050-2021-01302
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 5183301000
• Device Catalogue Number: 518330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2021
• Initial Date Manufacturer Received: 08/18/2021
• Initial Date FDA Received: 09/13/2021
• Supplement Dates Manufacturer Received: 10/12/2021
• Supplement Dates FDA Received: 11/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR