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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION PERMACOL 20X30 1.5MM MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION PERMACOL 20X30 1.5MM MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 5230-150
Device Problem Torn Material (3024)
Patient Problem Fistula (1862)
Event Date 08/22/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Initial reporter: (b)(6). Contact office: (b)(4). The device sample was returned on august 26, 2016.
 
Event Description
According to the reporter, during a relook laparotomy for abdominal sepsis, intraoperative findings included the biological implant has a wound in the left lower corner of the abdomen with thickening of the internal area and a longitudinal failure of approximately 16 cm. No signs of intra-abdominal sepsis or subcutaneous sepsis. No hematoma formation. The underlying bowel appeared healthy. During the procedure the left inferior quarter of the biological implant was excised, including the sutures securing it to the rectus sheath. Surgical closure of the wound to expedite wound closure. Antibiotics prescribed in icu continued. Last known patient status: stable.
 
Event Description
The device was not implanted in a contaminated site. The size of the initial hernia that needed repair was 15x20cm. The functionality of the device in this procedure was for the closure of the abdomen. The wound was closed by vac. The implant is still in the patient's body. The device was implanted (b)(6) 2016.
 
Manufacturer Narrative
(b)(4). No product was provided for evaluation. The provided pictures consist in photocopies in black and white attached in the theatre report. The visual examination of the provided pictures shows an open wound with the presence of suture points on one side of the biological mesh. Mesh degradation is visible as a longitudinal failure on several centimeters, however due to the picture quality it is not possible to determine if the degradation could be a tear, a mesh contamination or other. Mesh torn is visible as a longitudinal failure on several centimeters, no mesh contamination (infection) is observed. Without the sample a detailed investigation could not be performed. The conclusion is that improper use is highly suspected.
 
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Brand NamePERMACOL 20X30 1.5MM
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux
FR
Manufacturer (Section G)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux
FR
Manufacturer Contact
sharon murphy
60 middletown ave.
north haven, CT 06473
MDR Report Key5951306
MDR Text Key54748991
Report Number9615742-2016-00116
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K992556
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Model Number5230-150
Device Catalogue Number5230-150
Device Lot NumberAPD0804
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 Received09/23/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/14/2016 Patient Sequence Number: 1
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