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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON ETHICON PHYSIOMESH

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JOHNSON & JOHNSON ETHICON PHYSIOMESH Back to Search Results
Model Number PHY1015V
Device Problem Nonstandard Device (1420)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Hemorrhage/Bleeding (1888); Inflammation (1932); Ischemia (1942); Vomiting (2144); Complaint, Ill-Defined (2331); Obstruction/Occlusion (2422); Weight Changes (2607)
Event Date 10/03/2016
Event Type  Injury  
Event Description

In 2014, i had umbilical hernia repaired using ethicon physiomesh which has subsequently been recalled. An ed visit was made with a week or two after surgery for abdominal pain. On (b)(6) 2016, developed severe abdominal pain after eating. Went to ed, ct scan of abdomen showed partial small bowel obstruction. Admitted for observation, hydrated iv antibiotics and 5 days later required exploratory laparotomy. Surgical findings were acute and chronic inflammation, multiple adhesions, hemorrhage and ischemia in the small bowel. Open bowel resection 90 cm + of small bowel removed. Was on pca dilaudid for 4 days. Weight loss was 25 lbs. Discharged home for further workup. Pathology was negative for cancer. Gastric emptying negative. Mra negative. Upper endoscopy was negative. Unsure of reason. Still not feeling well with episodes of vomiting. Upon further research. I discovered the urgent field safety notice for the voluntary recall which i was never made aware of. I am further investigating as to whether or not there is a connection between the ethicon physiomesh and my experience.

 
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Brand NameETHICON PHYSIOMESH
Type of DeviceMESH
Manufacturer (Section D)
JOHNSON & JOHNSON
MDR Report Key6106182
MDR Text Key60281266
Report NumberMW5066083
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 11/14/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/14/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL NumberPHY1015V
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 11/14/2016 Patient Sequence Number: 1
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