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U.S. Department of Health and Human Services

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

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COLOPLAST A/S RESTORELLE  Y; SURGICAL MESH Back to Search Results
Model Number 5014202400
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Erosion (1750); Foreign Body Reaction (1868); Pain (1994); Urinary Incontinence (4572)
Event Type  Injury  
Event Description
As reported to coloplast, though not verified, legal representative stated the patient with this device experienced severe pelvic pain, foreign bodies in her bladder, and urinary incontinence.A doctor performed an additional surgery to remove pieces of the device that had eroded into her bladder to avoid any further damage.
 
Manufacturer Narrative
Coloplast has not been provided any corroborating evidence to verify the information contained in this report.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.
 
Manufacturer Narrative
Correction: item number, udi number.The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.
 
Event Description
Additional information received on 12/18/2022 as follows: on (b)(6) 2017 a prolene suture in the bladder was observed, most likely related to the burch procedure.
 
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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
usbes brian e schmidt
1601 west river road north
minneapolis, MN 55411
8007880293
MDR Report Key15656868
MDR Text Key302241972
Report Number2125050-2022-01127
Device Sequence Number1
Product Code OTO
Combination Product (y/n)N
PMA/PMN Number
K112322
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5014202400
Device Catalogue Number501420
Device Lot Number3613060
Was Device Available for Evaluation? No
Date Manufacturer Received12/18/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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