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

Device Problems Fracture (1260); Pumping Problem (3016)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

According to the available information, the patient could not pump the implant.The tube was found broken between the pump and cylinder.

Manufacturer Narrative

Medical device: item number: 9918s.Medical device: lot number: 769942.Date of explant: both (b)(6) 2022 were reported as the date of explant.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 information 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.

Manufacturer Narrative

An alpha i pump was received for evaluation.A separation was noted in the serialized exhaust tube.This was a site of leakage.The surfaces appeared to be rough and irregular, indicating stress was exerted.Partial separations within abrasion were noted on the non-serialized exhaust tube and inlet tube of the pump.These were not sites of leakage.Based on examination of the returned product, it was concluded that while in-vivo both the exhaust tubes and inlet tube of the pump had overlapped and abraded against one another.This positioning, in combination with device usage over time, may contribute to sufficient stress(s) to separate the serialized exhaust tubing.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.

• Brand Name: ALPHA I
• Type of Device: PENILE PROSTHESIS, INFLATABLE
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 13591835
• MDR Text Key: 286074007
• Report Number: 2125050-2022-00177
• Device Sequence Number: 1
• Product Code: JCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2022
• Initial Date FDA Received: 02/24/2022
• Supplement Dates Manufacturer Received: 03/23/2022
• Supplement Dates FDA Received: 03/28/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male