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U.S. Department of Health and Human Services

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

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ETHICON INC. PROLENE HERNIA SYSTEM UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Post Operative Wound Infection (2446)
Event Date 01/01/2008
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: not reported. Event related to patient in case 1 reported via mw # 2210968-2021-03431. Event related to patient in case 3 reported via mw # 2210968-2021-03433. Event related to patient in case 4 reported via mw # 2210968-2021-03434. Event related to patient in case 5 reported via mw # 2210968-2021-03435. Event related to patient in case 6 reported via mw # 2210968-2021-03436. Event related to patient in case 7 reported via mw # 2210968-2021-03437.

 
Event Description

It was reported in a journal article with title: wound infections and mesh infection following inguinal hernia surgery. The objective of this study is to present the outcome of wound infection and mesh infection following the inguinal hernia surgery using a prolene hernia system (phs) ethicon or prolene 3d patch (3dp) (ethicon) and mesh plug (ethicon). The author¿s observed wound infection from 2 to 7 weeks following surgery in 4 cases (0. 5% incidence). No mesh removal, infection or hernia recurrence and mesh resection surgeries were performed. Mesh infection was observed in 3 patients after inguinal hernia surgery that was performed at another hospital. Case 1- (b)(6) years old male incidence of infections during week 2 and week 7 following surgery. Case 2 ¿ (b)(6) years old male incidence of infections during week 2 and week 7 following surgery. Case 3 ¿ (b)(6) years old male incurred after bleeding on the day of surgery which was resolved by applying pressure, but a surgical hematoma formed on the following morning. Part of the wound self-collapsed on day 10 following surgery, so we punctured it. An infection also occurred 2 weeks after the surgery. Case 4 ¿ (b)(6) years old male incurred cellulitis along the entire length of the wound occurred in the third week following surgery. Inflammatory microbe (staphylococcus aureus. ) , slight fluid retention was observed with elevated fat concentration in the preperitoneal cavity and the inguinal canal subcutaneously under the right inguinal region. All 4 cases recovered in 1 to 6 weeks without having to resect the mesh. None of the cases experienced reoccurrence of infection or hernias. Case 5 ¿ (b)(6) years old male underwent a mesh resection surgery 6 months after the onset of infection because the infection onset in the second month following phs for an internal inguinal ring hernia and the fistula persisted even after incision and drainage was performed. Case 6 ¿ (b)(6) years old male 2 months after phs repair for right internal inguinal hernia. Formation of chronic fistula , inflammatory microbes (staphylococcus aureus ), abscess was observed in the inguinal canal and preperitoneal cavity. Case 7 ¿ (b)(6) years old male initial onset of delayed wound infection 5 years following mesh plug (ethicon) surgery for right external inguinal hernia. Thereafter, fistula formation repeatedly reoccurred. The fistula was closed, but the patient made a visit due to abscess formation. Redness, swelling, and tenderness at the right inguinal region was observed. Mri: light t2-weighted image was performed abscess was suspected due to part of the preperitoneal cavity and subcutaneous area in the right inguinal region exhibited high signals at the sites where the plugs were positioned. Pus excretion from the preperitoneal cavity via the internal inguinal ring following removal of an abscess in the inguinal was observed. There was no onset of infection recurrence, hernia recurrence, or chronic pain in any of the patients 18 months, 18 months, and 24 months after recovery, respectively.

 
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Brand NamePROLENE HERNIA SYSTEM 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
00754
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key11676757
MDR Text Key261732341
Report Number2210968-2021-03432
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK984220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
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 Received04/16/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/19/2021
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

Patient TREATMENT DATA
Date Received: 04/16/2021 Patient Sequence Number: 1
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