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U.S. Department of Health and Human Services

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

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ETHICON INC. PHYSIOMESH MESH, SURGICAL Back to Search Results
Lot Number UNKNOWN
Device Problem Migration or Expulsion of Device
Event Type  Injury  
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.

 
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.

 
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Brand NamePHYSIOMESH
Type of DeviceMESH, 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
GERMANY D-22851
Manufacturer Contact
kenneth clark
route 22 westp o box 151
somerville , NJ 08876
9082183547
MDR Report Key5782201
Report Number2210968-2016-10291
Device Sequence Number1
Product CodeFTL
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
Date FDA Received07/11/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/16/2016
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 TREATMENT DATA
Date Received: 07/11/2016 Patient Sequence Number: 1
Treatment
PROTACK
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