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

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

Patient Problems Pain (1994); Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/13/2012

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: chinese journal of tissue engineering research.2012; 16(21).  if further details are received at a later date a supplemental medwatch will be sent.Event related to ultrapro hernia system reported via mw # 2210968-2021-02062.Event related to prolene hernia system reported via mw # 2210968-2021-02063.Event related to prolene polypropylene suture reported via mw # 2210968-2021-02064.Event related to vicryl polyglactin 910 suture reported via mw # 2210968-2021-02065.Event related to prolene polypropylene suture (b)(6) year-old male patient reported via mw # 2210968-2021-02067.Event related to vicryl polyglactin 910 suture (b)(6) year-old male patient reported via mw # 2210968-2021-02068.

Event Description

It was reported in a journal article with title: comparison between ultrapro hernia system and prolene hernia system in the treatment of inguinal hernia.Heavyweight prolene hernia system (ethicon) as an anterior approach to preperitoneal inguinal hernia repair has become a commonly used technique at home and abroad.The objectives of the study was to compare the clinical outcomes of ultrapro hernia system (ethicon) and prolene hernia system (ethicon) in inguinal hernia repair.From february 2008 to december 2010, a total of 155 patients with unilateral inguinal hernia were operated on with ultrapro hernia system (79 patients; 76 male and 3 female patiets; age range: 35 to 71 years old; bmi: 62 ± 12) or prolene hernia system (76 patients; 74 male and 2 female patients; age range: 39 to 75 years old; bmi: 63 ± 14).All operations were performed by the same team of physicians.Antibiotics were given 0.5 hours before operation to prevent infection.The lower mesh of the ultrapro hernia system (ethicon) or the prolene hernia system (ethicon) was folded and placed into the preperitoneal space through the hernia ring opening and flattened fully, and the connector was placed in the hernia ring.If the hernia ring opening was large, the transversalis fascia could be sutured properly to reduce the hernia ring opening, so as to make the mesh more stable.The upper mesh of the ultrapro hernia system (ethicon) or the prolene hernia system (ethicon) was laid on the superficial surface of the transversalis fascia, with the upper edge beyond the arcuate edge and the lower edge reaching a point 2 cm beyond the pubic tubercle, and a gap was cut on one side of the patch to allow the spermatic cord (round ligament) to pass through.The patch was fixed using two stitches of prolene 2-0 suture (ethicon), with the outer end fixed on the inguinal ligament, and the inner end fixed on the deep surface of the external oblique aponeurosis.The external oblique aponeurosis was sutured continuously, the outer ring was reconstructed, and the subcutaneous tissues were sutured continuously using vicryl 4-0 suture (ethicon) and the skin was sutured intradermally.In the ultrapro hernia system group, reported complications included scrotal hematoma (n-5), subcutaneous effusion of the incision after repair (n-2), local pain at 3 months after repair (n-12), local pain at 6 months after repair (n-9), local pain at 12 months after repair (n-4), foreign body sensation at 3 months after repair (n-9), foreign body sensation at 6 months after repair (n-5), foreign body sensation at 12 months after repair (n-2).In the prolene hernia system group, reported complications included scrotal hematoma (n-4), subcutaneous effusion of the incision after repair (n-1), local pain at 3 months after repair (n-15), local pain at 6 months after repair (n-11), local pain at 12 months after repair (n-5), foreign body sensation at 3 months after repair (n-18), foreign body sensation at 6 months after repair (n-13), foreign body sensation at 12 months after repair (n-9), and case 2, a 61-year-old male patient with occasional pain and foreign body sensation in the right inguinal region.The results showed that the operation time, complications, postoperative recovery, recurrence rate and local pain scores of the two groups were similar, and the number of patients with foreign body discomfort in the ultrapro hernia system group was significantly lower than that in the prolene hernia system group, indicating that, as a light-weight repair material, the ultrapro hernia system has the advantages of sufficient tensile strength as well as safety, reliability and low local foreign body retention, and high quality of life, compared with the prolene hernia system, and it is worthy of clinical promotion and application.With regards to the patients in this study, the effect at current follow-up is positive.

• 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
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082182213
• MDR Report Key: 11427318
• MDR Text Key: 249572848
• Report Number: 2210968-2021-02066
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Other
• Type of Report: Initial
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2021
• 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: 02/03/2021
• 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
• Patient Age: 61 YR