Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ETHICON INC. PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC Back to Search Results
Catalog Number PROLIFTUNK
Device Problem Migration (4003)
Patient Problems Erosion (1750); Micturition Urgency (1871); Incontinence (1928); Pain (1994); Urinary Frequency (2275)
Event Type  Injury  
Manufacturer Narrative
This emdr represents supplemental report # (b)(4) for previously submitted mdr number 2210968-2018-75205, subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective may 15, 2019.The reports previously submitted as part of the exemption were not submitted in a format compatible with the public mdr database (maude) and are available through fda¿s mdr data files webpage, at https://www.Fda.Gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/mdr-data-files#asr.Therefore, this report does not represent a new reportable event.To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
 
Event Description
It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2012 and prolift was implanted.It was reported that the patient experienced pain and erosion of her internal bodily tissue following the procedure.It was reported that following insertion the patient experienced urinary frequency, urgency and incontinence.It was reported that she has undergone multiple surgeries and revisionary procedures.No additional information was provided.
 
Manufacturer Narrative
This emdr represents supplemental report # (b)(4) for previously submitted mdr number 2210968-2018-75205, subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective may 15, 2019.The reports previously submitted as part of the exemption were not submitted in a format compatible with the public mdr database (maude) and are available through fda¿s mdr data files webpage, at https://www.Fda.Gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/mdr-data-files#asr.Therefore, this report does not represent a new reportable event.To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
 
Event Description
It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2012 and prolift was implanted.It was reported that the patient experienced pain and erosion of her internal bodily tissue following the procedure.It was reported that following insertion the patient experienced urinary frequency, urgency and incontinence.It was reported that she has undergone multiple surgeries and revisionary procedures.No additional information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON SARL-NEUCHATEL
puits-godet 20
neuchatel
SZ  
Manufacturer Contact
elba bello
1000 route 202
raritan 08869
MDR Report Key12877127
MDR Text Key286002684
Report Number2210968-2021-12123
Device Sequence Number1
Product Code OTP
Combination Product (y/n)N
PMA/PMN Number
K013718
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial
Report Date 11/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberPROLIFTUNK
Was Device Available for Evaluation? No
Date Manufacturer Received01/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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;
Patient Age49 YR
Patient SexFemale
-
-