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

Catalog Number PHSUNK

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

Patient Problems Edema (1820); Hematoma (1884); Pain (1994); Seroma (2069); Hernia (2240); 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. The single complaint was reported with multiple events. There are no additional details regarding the additional events. Citation: surgical review 2005, 77, 1, 20-29. [(b)(4)].

Event Description

It was reported in a journal article with title: prolene hernia system (phs) in the treatment of inguinal hernias. The purpose of this retrospective study is to evaluate the results obtained following inguinal hernia treatment by means of the prolene hernia system (phs) method. Between nov1999 and dec2002, a total of 144 patients [n
=
138 male, n
=
6 female, mean age 65 years (18 to 95years)] with inguinal hernias were included in the study. Intraoperatively, decision concerning the size of the mesh was undertaken: medium (phsm), extended (phse) or large (phssl). After exploring the contents of the hernia sac it was reduced into the abdominal cavity or cut off, then ligated with absorbable sutures and fixed. After isolating the space in the preperitoneal area, an underlying pathc of phs mesh was placed, and the connector was inserted through the deep inguinal ring for oblique hernias or through the defect in the posterior wall of the inguinal canal for direct hernias. The onlay patch was placed on the posterior wall of the inguinal canal, and a small incision was made to insert either the spermatic cord or round ligament of the uterus. The onlay patch was sutured to the pubic tuberculum by means of single non-absorbable sutures. Postoperative complications included hernia recurrence (n
=
1) which was reoperated one month after, in which the phs mesh remained in place, and hernia ring was repaired by means of polypropylene plugs; wound suppuration (n
=
3) without the need to remove the mesh; seroma (n
=
1); scrotal edema persisting for 1 month (n
=
2); inguinal neuralgia/dysesthesia (n
=
2); chronic groin pain (n
=
6) continuous inguinal pain until 3months after the procedure, analgesia was not required; and hematoma (n
=
2). The prolene hernia system (phs) is an effective method of inguinal hernia repair with a low rate of postoperative complications and recurrences. Redon drainage in selected cases of inguinal hernia repair decreases the rate of local complications, such as hematomas and seromas.

• Brand Name: PROLENE HERNIA SYSTEM 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): J-PAC; 25 centre rd; somersworth NH 03878
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8478373
• MDR Text Key: 140771477
• Report Number: 2210968-2019-79950
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K984220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: PHSUNK
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/06/2019
• 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

Patient Treatment Data

Date Received: 04/03/2019 Patient Sequence Number: 1