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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROCEED MESH MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROCEED MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PROCEEDMUNK
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Pain (1994); Seroma (2069); Post Operative Wound Infection (2446)
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: hernia (2009); 13:13¿21. Doi: 10. 1007/s10029-008-0414-9. (b)(4).

 
Event Description

It was reported in a journal article title: pain, quality of life and recovery after laparoscopic ventral hernia repair. This prospective descriptive multicentre study was performed to characterise postoperative pain, period of recovery and quality of life in detail. From november 2005 to may 2006, 32 patients (19 male and 13 female; age range: 30-71 years; bmi: 21-42 kgm2) with hernias >3 cm prospectively underwent laparoscopic ventral hernia repair (lvhr) using ¿¿double-crown¿¿ titanium tack mesh fixation. All operations were performed under general anaesthesia and proceed mesh (ethicon) was used in all patients. Reported complications included seromas (n-23) which disappeared spontaneously after 6 months, superficial wound infection (n-10) which were treated successfully with oral antibiotics, postoperative subcutaneous hematoma/hematoma (n-6), postoperative pain vas score for the first three days (n-?) and postoperative pain vas score for the first week (n-?). In conclusion, lvhr was associated with considerable postoperative pain and fatigue in the first postoperative month, prolonging the time of convalescence and significantly affecting patients¿ quality of life up to 6 months postoperatively.

 
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Brand NamePROCEED MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-CORNELIA
cornelia
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8783628
MDR Text Key150816213
Report Number2210968-2019-84158
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK060713
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 07/02/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/12/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPROCEEDMUNK
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2019
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: 07/12/2019 Patient Sequence Number: 1
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