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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 SPM-149
Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Emotional Changes (1831); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Seroma (2069); Discomfort (2330); Impaired Healing (2378); Fluid Discharge (2686); Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of midline abdominal hernia. It was reported that after implant, the patient experienced open draining wound, seroma, and infection. Post-operative patient treatment included revision surgery and mesh removal.
 
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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
justin ellis
5920 longbow drive
8200 coral sea st ne
mounds view,mn, CT 55112
7635265677
MDR Report Key11083608
MDR Text Key224026911
Report Number9615742-2020-02931
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K915526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 08/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/01/2020
Device Model NumberSPM-149
Device Catalogue NumberSPM-149
Device Lot NumberA5A1274X
Was Device Available for Evaluation? No
Date Manufacturer Received08/24/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/28/2015
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: 12/28/2020 Patient Sequence Number: 1
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