MAUDE Adverse Event Report: COLOPLAST A/S ALPHA I 18CM SCROTAL; INFLATABLE PENILE PROSTHESIS

Model Number 5187401000

Device Problems Inflation Problem (1310); Excess Flow or Over-Infusion (1311); Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 08/12/2019

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, there was auto inflation and leak in the tubing.Additional information received stated the break was near the reservoir, the tubing was cut, the the reservoir was left in.

Manufacturer Narrative

The follow-up was created to document the additional event information and evaluation of the device.An alpha i pump, two cylinders and detached inlet tube with connector were received for evaluation.Examination and testing of the returned components revealed partial separations within abrasion on the non-serialized exhaust tube and inlet tube of the pump, inlet tube of the reservoir and exhaust tube of cylinder 1.Testing revealed none of these to be sites of leakage.No functional abnormalities were noted with any of the components received.The information received indicated auto inflation, leakage and tubing break.None of these were noted during examination and testing.Because no functional abnormalities were noted with the returned components the complaint could not be confirmed as reported.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, nonconformance's and capas revealed no trends for this lot.

Event Description

Additional information received indicated reservoir leakage.

• Brand Name: ALPHA I 18CM SCROTAL
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8983832
• MDR Text Key: 157185208
• Report Number: 2125050-2019-00743
• Device Sequence Number: 1
• Product Code: FHW
• 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
• Type of Report: Initial,Followup
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5187401000
• Device Catalogue Number: 518740
• Device Lot Number: 763977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2019
• Date Manufacturer Received: 08/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR