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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 Adhesion(s) (1695); Diarrhea (1811); Inflammation (1932); Nausea (1970); Pain (1994); Chills (2191); Hernia (2240); Weight Changes (2607); Decreased Appetite (4569)
Event Type  Injury  
Manufacturer Narrative

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 removal surgery and hernia repair surgery on (b)(6) 2015 and mesh was implanted during which the surgeon noted ¿a defect measuring approximately 10x6 cm in diameter was encountered. It contained portions of the mesh that was adherent to the hernia sac anteriorly and omentum posteriorly. It appeared as if the left side of the mesh had not adhered to the abdominal wall in a secure fashion. ¿ it was reported that the patient underwent removal surgery on (b)(6) 2017 during which the surgeon noted ¿old mesh from her prior repair intraabdominally that had not incorporated into the abdominal wall. ¿ it was reported the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss. The patient had had a previous mesh implanted on (b)(6) 2015 which is captured in separate file. No additional information was provided.

 
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Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.-CORNELIA
655 ethicon circle
cornelia GA 30531
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082182213
MDR Report Key11477613
MDR Text Key239794564
Report Number2210968-2021-02321
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 03/09/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/12/2021
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 Received03/05/2021
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: 03/12/2021 Patient Sequence Number: 1
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