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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 Material Perforation (2205); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Wound Dehiscence (1154); Adhesion(s) (1695); Purulent Discharge (1812); Emotional Changes (1831); Gangrene (1873); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Perforation (2001); Tachycardia (2095); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Fluid Discharge (2686); No Code Available (3191); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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 a hernia. It was reported that after implant, the patient experienced adhesions, infection and recurrence. Post-operative patient treatment included revision surgery.
 
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 an incarcerated left inguinal hernia. It was reported that after implant, the patient experienced adhesions, infection, recurrence, strangulated left inguinal hernia containing perforated and gangrenous sigmoid colon, tachycardia, wound dehiscence, prolapsing colostomy, purulent drainage from left inguinal incision, open wound and chronic drainage of the left inguinal wound. Post-operative patient treatment included revision surgery, mesh removal, exploratory laparotomy, partial colectomy, colostomy, wound vac placement due to pneumoperitoneum, takedown of colostomy, lysis of adhesions, left inguinal wound exploration due to left inguinal hernia, parastomal hernia and left inguinal hernia wound.
 
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 an incarcerated left inguinal hernia. It was reported that after implant, the patient experienced adhesions, infection, recurrence, strangulated left inguinal hernia containing perforated and gangrenous sigmoid colon, tachycardia, wound dehiscence, prolapsing colostomy, purulent drainage from left inguinal incision, and chronic drainage of the left inguinal wound. Post-operative patient treatment included revision surgery.
 
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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 Key9147024
MDR Text Key160933191
Report Number1219930-2019-05540
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
Type of Report Initial,Followup,Followup,Followup
Report Date 12/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2017
Device Model NumberSPM-35
Device Catalogue NumberSPM-35
Device Lot NumberA2M0656X
Was Device Available for Evaluation? No
Date Manufacturer Received12/01/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/07/2013
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: 10/02/2019 Patient Sequence Number: 1
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