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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN SURGIPRO MESH, SURGICAL, POLYMERIC

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COVIDIEN LP LLC NORTH HAVEN SURGIPRO MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN SURGIPRO MESH
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Cyst(s) (1800); Seroma (2069); Hernia (2240); Radiation Exposure, Unintended (3164); No Code Available (3191)
Event Date 01/01/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4). Title intra-abdominal giant infected seroma following laparoscopic inguinal hernia repair source hernia, volume 19, 2015 (795¿797) date of publication: 26 october 2013. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to literature source of study performed on 2015, the patient underwent laparoscopic transabdominal preperitoneal inguinal hernia repair for the left and right sides and was discharged on the same day and followed up at seven weeks and one year without complication. Six years later, the patient presented with abdominal and right lower limb pain and non-tender, immobile mass and was confined to the lower abdomen; upon ct scan, a large cystic mass confined by a thick contrast enhancing rim 17 x 15 x 16 cm determined to be an infected seroma. They drained and exploration of the cavity was performed under anesthesia. There was no recurrence after 6 months.
 
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Brand NameSURGIPRO
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
Manufacturer (Section G)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
Manufacturer Contact
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key8958554
MDR Text Key156393349
Report Number1219930-2019-05012
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 09/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN SURGIPRO MESH
Device Catalogue NumberUNKNOWN SURGIPRO MESH
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2019
Was Device Evaluated by Manufacturer? No Answer Provided
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: 09/03/2019 Patient Sequence Number: 1
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