MAUDE Adverse Event Report: COLOPLAST A/S (2BO)ALPHA I 18CM SCROTAL; INFLATABLE PENILE PROSTHESIS

Model Number 5187401000

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 06/27/2017

Event Type  Injury  

Manufacturer Narrative

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 of 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, tubing leakage.

Manufacturer Narrative

This follow-up mdr is created to document the evaluation of the returned device, the additional patient information, and the corrected device information received.A titan otr pump and two cylinders were received for evaluation.Examination and testing of the returned components revealed surface abrasion on all tubes and the strain relief of both exhaust tubes of the pump.A partial separation within abrasion is noted on the inlet tube of the pump.Testing revealed this not to be a site of leakage.No functional abnormalities are noted with the pump, cylinder #1, or cylinder #2.The information received indicated a malfunction - tubing leakage, but because no functional abnormalities were noted with the returned components, quality cannot confirm the complaint as reported.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type are captured in the product risk documentation.Based on this information, no further corrective action is required at this time.

• Brand Name: (2BO)ALPHA I 18CM SCROTAL
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: sarah o'gara ; 1601 west rivier road north; minneapolis, MN 55411 ; 6123578517
• MDR Report Key: 7271104
• MDR Text Key: 100081344
• Report Number: 2125050-2018-00142
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• 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: 5187401000
• Device Lot Number: 146469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR