MAUDE Adverse Event Report: ETHICON INC. PHYSIOMESH; MESH, SURGICAL

Device Problems Failure To Adhere Or Bond (1031); Appropriate Term/Code Not Available (3191)

Patient Problems Adhesion(s) (1695); Pain (1994); Seroma (2069); Hernia (2240); Injury (2348); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.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.(b)(4).

Event Description

It was reported in a journal article that the patient underwent a laparoscopic ventral and incisional hernia repair on unknown date and a mesh was implanted.Three or six months following the procedure, the patient possibly experienced a recurrence based on clinical and ultrasonographical examination and underwent a re-operation.The re-operation possibly revealed hernia recurrence with dense adhesions, including omentum and intestines that were adhered directly to the mesh.Incorporation of the mesh into the abdominal wall was poor, and the mesh was easily detached.The patient also experienced pain postoperatively at seven days, one month, three months and/or six months.It was also reported that the patient possibly experienced type i seroma and minor bleeding from the trocar site due to vessel injury.The patient received treatment intraoperatively and there was no need for blood transfusion.No further information is available.

• Brand Name: PHYSIOMESH
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; norderstedt D-228 51; GM D-22851
• Manufacturer Contact: kenneth clark ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183547
• MDR Report Key: 5717602
• MDR Text Key: 47138918
• Report Number: 2210968-2016-09701
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K093932
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/19/2016
• 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 Sequence Number: 1
• Treatment: SECURESTRAP
• Patient Outcome(s): Required Intervention