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

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.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 10/15/2020.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The following information was requested, but unavailable: 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 to the mesh device.

• Brand Name: PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10631588
• MDR Text Key: 210158256
• Report Number: 2210968-2020-07656
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PROMESHUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1