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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Sepsis (2067); Hernia (2240); Post Operative Wound Infection (2446); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/01/2021
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate. Component code: (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: annals of surgery (2021); doi: 10. 1097/sla. 0000000000005206. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number. Does the surgeon believe that ethicon products (physiomesh and proceed mesh) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products involved? patient demographics? events associated with proceed mesh device reported. Events associated with physiomesh device reported via mw # 2210968-2021-11560.
Event Description
It was reported in a journal article with title: reoperation for recurrence is affected by type of mesh in laparoscopic ventral hernia repair: a nationwide cohort study. The purpose of this nationwide cohort study on a prospectively collected data from the (b)(6) ventral hernia database and the (b)(6) national patient register was to investigate the effect of different meshes on the reoperation for recurrence rate during laparoscopic ventral hernia repair. Between january 1, 2007 to april 1, 2020, 2,802 patients with primary hernias and 2,608 patients with incisional hernias, who underwent laparoscopic ventral hernia repair with an intraperitoneally placed mesh, were included in the study. In the primary ventral hernia cohort, surgery was performed using physiomesh¿ in 599 patients (193 female; mean age of 54 (46-64) years), proceed¿ surgical mesh in 133 patients (31 female; mean age of 54 (46-61) years), and competitor devices in the rest of the patients. In the incisional ventral hernia cohort, surgery was performed using physiomesh¿ in 486 patients (268 female; mean age of 60 (49-69) years), proceed¿ surgical mesh in 150 patients (82 female; mean age of 59 (48-67) years), and competitor devices in the rest of the patients. Reported complications include abdominal pain (n
?), deep wound infection (n
?), gastrointestinal disease (n
?), and sepsis (n
?) requiring readmission within 90 days; and hernia recurrence (n
?) requiring reoperations. In conclusion, for laparoscopic repair of primary hernias, proceed¿ surgical mesh and physiomesh¿ had in this study a higher reoperation rate for recurrence than dynamesh®-ipom. For incisional hernia, several meshes had in this study higher rates of reoperation for recurrence compared with the ventralight¿ st mesh, and these meshes were physiomesh¿, ventralex¿ hernia patch, parietex¿ composite (incl. Optimized), and proceed¿ surgical mesh. When it comes to reoperation rates for recurrence, the findings in this study indicate that the type of mesh may correlate with the outcome, and the choice of mesh should depend on the hernia being either a primary or an incisional hernia. Moreover, it could be considered if meshes with higher reoperation rates should be recalled.
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Manufacturer (Section D)
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
655 ethicon circle
cornelia GA 30531
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key12831777
MDR Text Key285754248
Report Number2210968-2021-11559
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 11/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Date Manufacturer Received10/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/17/2021 Patient Sequence Number: 1