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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Seroma (2069); Post Operative Wound Infection (2446); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(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.Citation: hernia (2007) 11:163¿167; doi 10.1007/s10029-007-0189-4; published online: 2 february 2007.(b)(4).

Event Description

It was reported via journal article: "title: comparison of prosthetic mesh repair and tissue repair in the emergency management of incarcerated para-umbilical hernia: a prospective randomized study" authors: n.A.Abdel-baki · s.S.Bessa · a.H.Abdel-razek citation: hernia (2007) 11:163¿167; doi 10.1007/s10029-007-0189-4; published online: 2 february 2007.The objective of this prospective randomized study was to compare results from prosthetic repair and tissue repair in the management of the acutely incarcerated puh.From may 1, 2004 until december 1, 2005, 42 patients with acutely incarcerated puh were prospectively randomized to either the prosthetic-repair group (n=21) (mean age 49.6±15.8 years, male n=1, female n=20) or the tissue-repair group (n=21) (mean age 48.1±15.5 years, female n=21).A transverse elliptical incision overlying the hernia was used.After excision of the sac and dealing with its contents, the defect was vertically closed by use of simple interrupted non-absorbable sutures (prolene 1, ethicon).In the tissue-repair group, herniorrhaphy was performed by inverting the medial 1.5¿2 cm of the rectus sheath on either side over the closed defect and suturing both sides together using simple interrupted non-absorbable sutures (prolene 1, ethicon), thus creating a second layer of repair and simulating the so-called keel method.These sutures extended for at least 2¿4 cm beyond the defect.In the prosthetic-repair group, skin and subcutaneous flaps were elevated to fit a 15 cm x 15 cm monofilament polypropylene mesh (prolene, ethicon).The mesh was then fixed to the abdominal wall muscles as an onlay patch using interrupted non-absorbable sutures (prolene 2/0, ethicon).Resection anastomosis of non-viable bowel was performed in a single layer, sero-muscular extra-mucosal manner using interrupted absorbable sutures (vicryl 3/0, ethicon).Complications in the prosthetic repair group included wound infection (n=2), seroma (n=2) which necessitated re-insertion of a catheter tube drain under local anesthesia and prolonged redivack effluent (n=1).Complications in the tissue-repair group included wound infection (n=3) and recurrence (n=4).Only one of the patients who had a mesh implanted after bowel resection developed wound infection.All wound infections encountered in this study were successfully treated by local measures and appropriate antibiotics guided by culture and sensitivity studies.In conclusion, use of prosthetic repair for emergency management of incarcerated puh is safe and leads to superior results, in terms of recurrence, compared with conventional tissue repair.The presence of non-viable intestine cannot, furthermore, be regarded as a contraindication for prosthetic repair.

• 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 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8918669
• MDR Text Key: 157515414
• Report Number: 2210968-2019-85960
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention