MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE Y; SURGICAL MESH

Model Number 5014202400

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Fatigue (1849); Pain (1994); Burning Sensation (2146); Ambulation Difficulties (2544)

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 or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.The lot number (4185366) was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.Date of occurrence not reported but estimated to be in (b)(6) 2022.

Event Description

According to available information, the patient with this device reported the following symptoms/events (translated from french): "pain in the vagina (burning sensation) electric shock difficult to walk (no more than 30 minutes in small steps) difficult to sit and stand (as the day progresses the pains increase) going down the stairs no energy fatigue i must always wear shoes to minimize the impact on the ground empty my bladder and rectum as often as possible.".

Manufacturer Narrative

B1 corrected from "adverse event & product problem" to "adverse event" h6 annex a code updated from a27 "appropriate term/code not available" to a24 "adverse event without identified device or use problem".

Event Description

Additional information received further reported that the patient had received pain clinic medications (one injection), and had attempted physiotherapy, osteopathy, had been examined by a urologist, was examined in the hospital, had visited a physiatrist, and followed-up with gynecology.The device remained implanted.

Manufacturer Narrative

Correction: the h2 aware date provided on the initial mdr was 06jun2022 but is being corrected to 22jun2022.

• Brand Name: RESTORELLE Y
• Type of Device: SURGICAL MESH
• 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: 14965459
• MDR Text Key: 295595132
• Report Number: 2125050-2022-00708
• Device Sequence Number: 1
• Product Code: OTO
• UDI-Device Identifier: 05708932483834
• UDI-Public: 05708932483834
• Combination Product (y/n): N
• PMA/PMN Number: K112322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2022

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
• Device Expiration Date: 08/07/2017
• Device Model Number: 5014202400
• Device Catalogue Number: 501420
• Device Lot Number: 4185366
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/02/2022
• Initial Date FDA Received: 07/08/2022
• Supplement Dates Manufacturer Received: 07/23/2022; 10/13/2022
• Supplement Dates FDA Received: 08/24/2022; 10/13/2022
• Date Device Manufactured: 08/08/2014
• 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 Sex: Female