MAUDE Adverse Event Report: JOHNSON & JOHNSON INTERNATIONAL PHYSIOMESH OVAL MESH, SURGICAL, POLYMERIC

Catalog Number PHY1015V

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Adhesion(s) (1695); Fever (1858); Hemorrhage/Bleeding (1888); Inflammation (1932); Ischemia (1942); Pain (1994); Rash (2033); Vomiting (2144); Weakness (2145); Numbness (2415); Obstruction/Occlusion (2422); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 10/03/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4). To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. This medwatch report is in response to receipt of maude event report # mw5066083.

Event Description

It was reported that the patient underwent an umbilical hernia repair procedure on (b)(6) 2014 and the mesh was implanted. Within a week or two after the procedure, the patient was seeing a doctor for abdominal pain. In 2016, the patient developed severe abdominal pain after eating and ct scan of abdomen showed a partial small bowel obstruction. The patient was admitted for observation and treated with hydrated iv antibiotics. Five days later the patient required exploratory laparotomy. Surgical findings were acute and chronic inflammation, multiple adhesions, hemorrhage and ischemia in the small bowel. During the open bowel resection, ninety centimeters of small bowel was removed. The patient was on pca dilaudid for four days. Weight loss was twenty five pounds. The patient was discharged home for further workup. Pathology was negative for cancer. Gastric emptying , mra and upper endoscopy were negative as well. The doctor is unsure of reason. The patient is still not feeling well with episodes of vomiting. Additional information will be requested.

Manufacturer Narrative

(b)(4). In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria. This medwatch report is in response to receipt of the maude event report. It was reported that symptoms started in 2016 such as both hands and arms numbness and weakness throughout the body that continued to get worse. The patient also developed rash on face, neck and back. The lyme disease test was negative. In 2016, the patient experienced a fever, body numbness and had difficulty walking. As the patient stated, the patient was treated with antibiotics for a month. One week after admission for small bowel obstruction, the patient was hospitalized again and developed right upper thigh numbness during this hospitalization. It was also reported that there was three feet of small intestines removed and the patient continued to have pain after the surgery with 30 lb weight loss. After hospitalization, the patient underwent endoscopy, gastric emptying test, mre and mri of brain and spine ms protocol. All test results were negative. The patient continued to have abdominal pain and feel uncomfortable. In 2017, the patient underwent a mesh removal and lysis of multiple adhesions surgery. The mesh was adhered to the small intestine starting to obstruct again. The patient is still recovering from the second surgery and still have numbness in the right upper thigh. It was also reported that the surgeon was able to remove entire body of mesh robotically. The mesh explant date is (b)(6) 2017.

• Brand Name: PHYSIOMESH OVAL
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): JOHNSON & JOHNSON INTERNATIONAL; leonardo da vincilaan 15; diegem 1831 ; BE 1831
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; norderstedt D-228 51; GM D-22851
• Manufacturer Contact: krystina laguna ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183043
• MDR Report Key: 6264418
• MDR Text Key: 65300248
• Report Number: 2210968-2017-60028
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K093932
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/30/2016
• Device Catalogue Number: PHY1015V
• Device Lot Number: HE8CDCB1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2014
• 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: 01/19/2017 Patient Sequence Number: 1