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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-35
Device Problems Degraded (1153); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Adhesion(s) (1695); Emotional Changes (1831); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Hernia (2240); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
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 hernia. It was reported that after implant, the patient experienced significant left inguinal pain and left epididymal pain, swelling, scar tissue, hard mesh, inflammation, entanglement of the spermatic cord, chronic foreign body reaction, infection, mesh encased, recurrence, scarring, lack of adequate ingrowth, nerve damage, spermatic cord injury, failure of mesh, mental pain, disability, impairment, loss of enjoyment of life, and adhesions. Post-operative patient treatment included remove his vas deferens/epididymis and removal of mesh.
 
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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
tracy landers
5920 longbow drive
boulder, CO 80301
3035816943
MDR Report Key14029069
MDR Text Key288766598
Report Number1219930-2022-01222
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
Report Date 04/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSPM-35
Device Catalogue NumberSPM-35
Device Lot NumberAIE0094
Was Device Available for Evaluation? No
Date Manufacturer Received03/16/2022
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: 04/06/2022 Patient Sequence Number: 1
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