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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-W
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); 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 a left inguinal hernia. It was reported that after the onlay implant, the patient experienced adhesions, pain, scar tissue, and scarring. Post-operative patient treatment included revision surgery, injections, diagnostic laparoscopy, removal of mesh, hernia repair with new mesh, and physical therapy.

 
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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 Key12068037
MDR Text Key258393354
Report Number1219930-2021-02569
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK915526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 06/25/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/25/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSPM-35-W
Device Catalogue NumberSPM-35-W
Device LOT NumberA1L0861
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/09/2021
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: 06/25/2021 Patient Sequence Number: 1
Treatment
GORE BIO-A HERNIA PLUG (LOT # 9844247)
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