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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 PCDN1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Necrosis (1971); Pain (1994)
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. (b)(4) submitted for the adverse event which occurred on (b)(6) 2019. (b)(4) submitted for the adverse event which occurred on (b)(6) 2019.

 
Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2009 and mesh was implanted. It was reported that the patient underwent an appendectomy on (b)(6) 2019 during which the surgeon noted ¿the small bowel and omentum had adhered to the underside of the previously placed midline umbilical mesh. The patient was in septic shock with acute kidney failure secondary to bowel perforation that was possibly caused because of the dense intraabdominal adhesions to prior mesh and tacts. ¿ an open surgery was performed on (b)(6) 2019 during which the surgeon noted ¿multiple loops of small bowel and omentum were found densely adhered and tethered to the 10 cm previous underlaid midline round mesh. He dissected free the adhesions and resected approximately 30 cm segment of the injured small bowel. Due to the inflamed peritonitis and serositis, he irrigated the abdominal wound, placed vacuum assisted drainage and left the wound opened. ¿ the patient underwent removal surgery on (b)(6) 2019 during which the surgeon noted ¿he performed a small bowel anastomosis, repair the mesenteric defects, irrigate and debride the necrotic tissues. ¿ it was reported that the patient experienced severe pain, inflammation and bowel injuries. No additional information was provided.

 
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Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan 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 Key11467551
MDR Text Key239465281
Report Number2210968-2021-02279
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,Followup,Followup
Report Date 03/09/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/11/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2010
Device MODEL NumberPCDN1
Device Catalogue NumberPCDN1
Device LOT NumberBCG114
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/30/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/23/2009
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: 03/11/2021 Patient Sequence Number: 1
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