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

Lot Number UNKNOWN

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Adhesion(s) (1695); Hernia (2240)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported that a patient underwent a hernia repair procedure on an unknown date and mesh was implanted using absorbatack for fixation.The mesh fell off into abdominal cavity and adhered to bowel loop.The professor opines that the fixation device was not compatible to the mesh and believes this was a result of mesh fixation problem.

Manufacturer Narrative

Date sent to fda: 05/05/2016, (b)(4).

• 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: ken clark ; route 22 west po box 151west p; o box 151; somerville, NJ 08876 ; 9082183547
• MDR Report Key: 5612856
• MDR Text Key: 43839402
• Report Number: 2210968-2016-08573
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2016
• Was Device Evaluated by Manufacturer?: No
• 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): Other