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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 Abscess (1690); Inflammation (1932); Necrosis (1971); Pain (1994); Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative

(b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.

 
Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2019 and mesh was implanted. It was reported that the patient underwent revision surgery on (b)(6) 2019. It was reported that the patient experienced severe and chronic pain/ discomfort, tingling feeling/ sensation, inflammation, infection, abdominal wall abscess, fluid collection, necrosis, open draining wound and wound vac. 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
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key11791057
MDR Text Key250370475
Report Number2210968-2021-04344
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK060713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 05/04/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/07/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPCDG1
Device Catalogue NumberPCDG1
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/03/2021
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? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/07/2021 Patient Sequence Number: 1
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