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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adult Respiratory Distress Syndrome (1696); Hematoma (1884); Seroma (2069); Post Operative Wound Infection (2446); Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided. The single complaint was reported with multiple events. There are no additional details regarding the additional events. Citation of article: acta bio medica 2003; 74; suppl. 2: 38-40.
 
Event Description
It was reported in a journal article with title: dynamic suture less repair of incisional hernia. From january 1995 to december 2003, 93 patients (64 males and 29 females, mean age 64, 3) underwent surgery for incisional hernia repair in our division. In 79 cases (85%) the hernia was in medial supraumbilical area, in 7 cases it was sub umbilical, in 4 cases it was in sub costal area and in 3 cases it was positioned in the left iliac space. In 82 cases the abdominal wall defect was of middle large size (
=
10 cm), while in 13 cases we observed the presence of a large loss of tissue. A preoperative ultrasonography and respiratory function analysis was made in all cases, while in the most complicated hernias (7cases,7,5%) a preoperative ct scan was found to be necessary. When respiratory functionality resulted to be low, a preoperative medical and physical therapy, together with the use of curative pneumoperitoneum, was done for 3 months. The surgical intervention was performed in 52 cases (group a) with a classic rives technique, with apposition of a prolene mesh (ethicon) in the subaponeurotic space, and fixation of the mesh with transcutaneous not reabsorbable stitches. In 41 cases (group b) the intervention was performed with a personal technique, with apposition of an hertra 0 rigid, memory controlled mesh between the rectum abdomini muscle and its posterior fascia, without fixation with stitches. In all cases drainage was positioned at the end of the intervention, and was pulled when it was draining less than 10cc of serum. Reported complications included intraparietal haematoma (n
=
3), subcutaneous hematoma (n
=
2), retrofascial haematoma (n
=
4), wound infection (n
=
4) (in 1 case it was necessary to remove the prosthesis). Respiratory complications (n
=
3) , which solved with medical and rehabilitative therapy , cardiovascular complication (n
=
1) and subcutaneous seroma (n
=
3). In conclusion the presented technique seems to offer advantages in the management of incisional hernia; the use of hertra 0 mesh simplifies rives technique, improving its resistance to infections.
 
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Brand NamePROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
982 road 183 km 8.3
san lorenzo 00754
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key11905498
MDR Text Key266279997
Report Number2210968-2021-05084
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received06/04/2021
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?
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 05/28/2021 Patient Sequence Number: 1
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