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 Cyst(s) (1800); Inflammation (1932); Pain (1994); Hernia (2240); Hematuria (2558); No Code Available (3191)

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.

Event Description

It was reported by an attorney that the patient underwent a laparoscopic incisional hernia repair on (b)(6) 2012 and mesh was implanted.It was reported that the hernia returned within days of the surgery, and on (b)(6) 2012, the patient was admitted again to the hospital to repair a recurrent incisional hernia.The surgeon noted that he could easily visualize the superior aspect of the mesh that had been placed laparoscopically and the tail that had been intended to hang down well over the symphysis pubis as one would use a long shirttail pulled up into the wound.The surgeon trimmed this off and then actually secured this to the undersurface of the abdominal wall.The surgeon then, via an open repair surgery, implanted another mesh.On (b)(6) 2013, the patient experienced a rush of extreme pain.Her bowels had come loose through her muscular wall, and was rushed into surgery.The doctor at another facility performed the surgery.It was noted that the mesh had disintegrated into the intestines and bowels, and the surgeon was not able to remove all the mesh.The patient continues to experience hematuria and chronic interstitial cystitis.She cannot lift more than 10 to 12 pounds without pain and inflammation.No additional information was provided.

Manufacturer Narrative

In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6561663
• MDR Text Key: 74989994
• Report Number: 2210968-2017-60220
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093932
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2014
• Device Catalogue Number: PHY1015V
• Device Lot Number: ED8GGHAD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR