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

Model Number 5014201400

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Type  Injury  

Event Description

As reported to coloplast, though not verified, (b)(6) 2009 post op shortness of breath.Poor air movement bilaterally on auscultation.Diagnosed with probable copd with atelectasis secondary to surgery.On (b)(6) 2009 post-op diagnosis of pneumonia with shortness of breath (sob).Elevated wbc, with need for supplemental o2 and iv antibiotics.Claimant hospitalized for extended period of time and discharged to a skilled nursing facility.On (b)(6) 2009 pelvic pain postoperatively.A right-sided bartholin's gland cyst which is 2 1/2 centimeters in diameter is noted after claimant complains of vaginal bulging.The cyst was tender to palpation.Plan: removal of cyst [unrelated to coloplast product].No other adverse patient effects were reported.

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

Manufacturer Narrative

The device was not returned for evaluation.Without the benefit of analyzing the device, quality cannot confirm any observations and cannot comment on the condition of the device.If the device becomes available, or additional information is received, quality will re-evaluate this complaint in accordance to procedures.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.

Event Description

According to the available information the titan was implanted on (b)(6) 2019 and revised on (b)(6) 2021 due to a tubing fracture at the left cylinder.

• Brand Name: RESTORELLE Y CONTOUR
• 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: 13014494
• MDR Text Key: 285840837
• Report Number: 2125050-2021-01786
• Device Sequence Number: 1
• Product Code: OTO
• 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,Followup
• Report Date: 01/07/2022

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 Model Number: 5014201400
• Device Catalogue Number: 501420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2021
• Initial Date FDA Received: 12/15/2021
• Supplement Dates Manufacturer Received: 11/28/2021
• Supplement Dates FDA Received: 01/07/2022
• 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