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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROCEED*SURG MESH/MULTI LYR MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROCEED*SURG MESH/MULTI LYR MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCDG1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Hemorrhage/Bleeding (1888); Inflammation (1932); Ischemia (1942); Hernia (2240); Obstruction/Occlusion (2422)
Event Type  Injury  
Manufacturer Narrative
The batch number could be verified. Our manufacturing q-system assures, that production and process controls are in place to ensure that batches confirm to the applicable specifications before they are distributed.   the non-integration of an endosseous dental implant during the healing phase is a known inherent risk of the treatment with dental implants. Most implant failures occur before occlusal loading (analainen et al. 2009). Based on clinical studies about 1-3% of the implants fail within the first year after implantation (ganeles et al. 2008). Implants may have to be removed in case one or more of the implant success criteria are not met. Implant success criteria according to buser et al. (1991) are: absence of persistent subjective complaints such as pain, foreign body sensation and /or dysesthesia, absence of a recurrent peri-implant infection with suppuration, absence of implant mobility, absence of a continuous radiolucency around the implant. The manufacturer's trend analysis confirms that the reported early failure rate associated with its dental implants is below the expected failure rate for this treatment as published in the scientific literature.
 
Event Description
It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2014 and mesh was implanted. It was reported that the patient underwent recurrent hernia repair surgery on (b)(6) 2017 during which the surgeon noted ¿he was forced to convert to an open exploratory laparotomy due to extensive adhesions and small bowel involvement with the previously placed mesh. The affected bowel was noted to be matted and hemorrhagic and to repair the bowel obstruction he was ultimately forced to remove approximately eleven inches of small bowel. ¿ it was reported that the patient experienced dense adhesions, small bowel obstructions, acute and chronic inflammation, ischemic bowel, chronic and intractable abdominal pain. No additional information was provided.
 
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Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-CORNELIA
655 ethicon circle
cornelia GA 30531
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key13090675
MDR Text Key288189346
Report Number2210968-2021-12993
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2016
Device Model NumberPCDG1
Device Catalogue NumberPCDG1
Device Lot NumberHHG134
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/18/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/27/2021 Patient Sequence Number: 1
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