MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE - UNKNOWN; INFLATABLE PENILE PROSTHESIS

Model Number 5013202400

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Pain (1994); Dyspareunia (4505)

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.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

As reported to coloplast, though not verified, between (b)(6)2017-(b)(6)2020: posterior vaginal wall and rectum tenderness, spasm of pelvic muscles around vagina, vaginal pain, worst when she first urinates, spasm of pelvic muscles around vagina, pelvic pain and a feeling that her repair is slipping, tender bladder, uti.Pelvic pain, constipation (chronic), bladder tender, tight pelvic floor musculature, tender throughout pelvic exam.Physical therapy: pelvic floor muscle hypertonus, pelvic pain, dyspareunia, incontinence, muscle spasms, pfm pain, constipation.Severe pelvic pain, pelvic floor spasm and bladder pain.Pelvic floor spasm and pain.Pelvic pain from levator spasm.Vaginal prolapse (no prolapse felt on exam) referred to ob-gyn.Recurrent vaginal prolapse (rectocele or enterocele) after car accident, posterior wall tenderness no other adverse patient effects were reported.

• Brand Name: RESTORELLE - UNKNOWN
• Type of Device: INFLATABLE PENILE PROSTHESIS
• 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: 12980791
• MDR Text Key: 284881009
• Report Number: 2125050-2021-01755
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932483223
• UDI-Public: 05708932483223
• Combination Product (y/n): N
• PMA/PMN Number: K112322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2020
• Device Model Number: 5013202400
• Device Catalogue Number: 501320
• Device Lot Number: 5550425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/30/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Female