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

Lot Number UNKNOWN

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Cellulitis (1768); Fistula (1862); Hematoma (1884); Pain (1994); Seroma (2069); Hernia (2240); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts are being made to obtain information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.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 that a randomized trial was completed to compare main fixation devices in regard to pain and recurrence in laparoscopic ventral incisional hernia repair (lvihr) and mesh was implanted.It was reported that the patients experienced post-operative pain, seroma, hematoma, trocar hernia, cellulitis, hernia recurrence and mesh migration into the small bowel.As a result of the mesh migration, the patient was readmitted to the hospital with an enterocutaneous fistula.The patient was treated with mesh extraction and segmental small bowel resection in the po third month.Additional information has been requested.

• 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: 5782201
• MDR Text Key: 49168198
• Report Number: 2210968-2016-10291
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K093932
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/16/2016
• Initial Date FDA Received: 07/11/2016
• 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: PROTACK
• Patient Outcome(s): Required Intervention