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U.S. Department of Health and Human Services

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

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COVIDIEN LP LLC NORTH HAVEN UNKNOWN SURGIPRO MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number SPMM-35
Device Problems Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Perforation (2001); Sepsis (2067); Seroma (2069); Hernia (2240); Ulcer (2274); Injury (2348); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic. The fda was notified of this large complaint receipt. Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target. 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. Product was used for therapeutic treatment of a ventral hernia. It was reported that after implant, the patient experienced adhesions, abscess, seroma, perforated ulcer, pneumoperitoneum, abdominal pain, experienced lethargy, sepsis and recurrence. Post-operative patient treatment included revision surgery, lysis of adhesions, drainage of seroma, partial omentectomy, excision of previous mesh, drainage of abscess, evacuation of coagulated blood and enteric contents/debris, mobilization of right colon with kochers maneuver, primary repair of posterior d2 perforated ulcer with omental patch reinforcement, abdominal washout, and repair of hernia.
 
Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic.  the fda was notified of this large complaint receipt.   due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target. 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. Product was used for therapeutic treatment of a ventral hernia. It was reported that after implant, the patient experienced adhesions, abscess, seroma, perforated ulcer, and recurrence. Post-operative patient treatment included revision surgery, lysis of adhesions, drainage of seroma, partial omentectomy, excision of previous mesh, drainage of abscess, evacuation of coagulated blood and enteric contents/debris, mobilization of right colon with kochers maneuver, primary repair of posterior d2 perforated ulcer with omental patch reinforcement, abdominal washout, and repair of hernia.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
(b)(4). 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 resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. Preoperative and postoperative diagnosis was ventral hernia. ­­­­­­­­­ the procedure performed was robot-assisted ventral hernia repair with mesh. She has had surgical revision, adhesions, and abscess.
 
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Brand NameUNKNOWN SURGIPRO MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
ct 06473
MDR Report Key7174717
MDR Text Key279935487
Report Number1219930-2018-00238
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K915526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup,Followup
Report Date 01/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Model NumberSPMM-35
Device Catalogue NumberSPMM-35
Device Lot NumberA4K1427X
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/09/2018 Patient Sequence Number: 1
Treatment
UNKABSTACK(LOT#: UNKNOWNO
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