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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PROMESHUNK
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Hernia (2240); Obstruction/Occlusion (2422); Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative

(b)(4). To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. The patient demographic info: age, weight, bmi at the time of index procedure date and name of initial surgical procedure what were current symptoms following the index surgical procedure? onset date? what was surgical approach (open, laparoscopic or other)? any concurrent surgeries or procedures? were pre-existing adhesions noted during the procedure? what was the location and severity of adhesions? please provide details of midline laparotomy and bowel resection. Describe relationship of adhesion to device implanted. Please provide the date of reoperation was the hernia repair associated with this event performed on primary or recurrent hernia? what was the defect size/type/location of the hernia associated with this event? mesh size and overlap? what tissue layer did you place the mesh? if applicable, closure of the defect (yes or no), use of stay sutures (how many), permanent or absorbable? if applicable, the mesh fixation technique: device and technique? (single or double crown; spacing between implants). Were there any surgical instruments used in the placement of the mesh that might have damaged the mesh? e. G. Graspers crimping the mesh fibers how much time from initial hernia repair to hernia recurrence? was there any triggering event prior to present recurrence? (e. G. Weight gain, sneezing, coughing, strenuous activity)? how was the recurrence diagnosed? mesh location and integrity. Was any deficiency or anomaly of the mesh? if yes, please describe it. Are there any pictures available? product code/name. Please confirm the lot number as leb136 does not correspond with the mesh device if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

 
Event Description

It was reported that a patient underwent a hysteropexy procedure on an unknown date and the mesh was implanted. It was reported that three months post implant of prolene hysteropexy mesh, patient developed adhesions and small bowel obstruction. It was also reported that the patient required a midline laparotomy and bowel resection. It was reported that the small bowel was adherent to the suture line over the mesh, and the rest of the small bowel adhered leading to obstruction. It was reported that the patient also developed a recurrent prolapse and a large incisional hernia, this required further surgical treatment 2019 including a revision of her hysteropexy. It was also reported that the device remains implanted.

 
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Brand NamePROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
avenida de las torres 7125
col salvacar
ciudad juarez 32604
MX 32604
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082183429
MDR Report Key10631588
MDR Text Key210158256
Report Number2210968-2020-07656
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/09/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/05/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPROMESHUNK
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2020
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

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