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

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

Patient Problem Urinary Retention (2119)

Event Date 09/03/2011

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: infect inflamm rep, vol.12, no.3, september 2011.  event related to the prolene 3d patch mesh reported via mw # 2210968-2021-03475.

Event Description

It was reported in a journal article with title: experience of the use of prolene 3d patch and prolene hernia system in the repair of inguinal hernia: report of 106 cases.The objective of this study is to observe the effects of prolene 3d patch (3dp) and prolene hernia system (phs) in the repair of inguinal hernia.From january to august 2009, 106 patients with inguinal hernia that were repaired with 2 types of patches were included in the study.There were 98 males and 8 females with a mean age of 59.4 +/- 13.7 years (range 25 to 81 years).There were 98 cases of unilateral hernia, including 97 cases of primary hernia and 1 case of recurrent hernia.There were eight cases of bilateral hernia.There were 12 cases concomitant with chronic respiratory diseases, 4 cases with prostatic hypertrophy, 2 cases with hypertension, 4 cases with diabetes mellitus, and 4 cases with long-term constipation.For the 57 cases with small-diameter hernia ring and no obvious defect of transverse abdominal fascia, the prolene 3d patch (ethicon) was used; for the 49 patients with large-diameter hernia ring, weak or obvious defect of transverse abdominal fascia, and no serious contamination of the operative area, prolene hernia system (ethicon) was used.There were no complications of the heart, brain, and lung after the operation.The postoperative follow-up was 18 to 26 months, with an average of 20 months, with no recurrence.Postoperative complications include acute urinary retention (n=2), and after indwelling the catheter, spontaneous urination was restored 1 to 2 days later.

• Brand Name: PROLENE HERNIA SYSTEM MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; p.o. box 1409; norderstedt D2284 1; GM D22841
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11682936
• MDR Text Key: 261984156
• Report Number: 2210968-2021-03476
• 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: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2021
• 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: 03/19/2021
• 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