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

Model Number SPM-149

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Respiratory Distress (2045); Thrombosis (2100); Weakness (2145); Discharge (2225); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Weight Changes (2607); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Concomitant product: spm-149 surgipro mesh und 35 x 22cm multi (lot # a2k38).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 an unspecified adverse outcome.

Manufacturer Narrative

Additional information: fda site id, mfr site id, patient code: c64343(decreased hemoglobin, decreased urine output, tense abdomen, open lesion).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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 incisional hernia.It was reported that after implant, the patient experienced decreased hemoglobin, chelonae causing wound infection, mesh coated with purulent material, increased respiratory distress, decreased urine output, tense abdomen, dilated bowel and roux limb, clot inright flank and into the pelvis, the two pieces of mesh were more tense, large abdominal open wound with continued drainage, exposed mesh, weakness, weight loss, infected mesh, punctate opening, open lesion, loosening of mesh, and extruding mesh.Post-operative patient treatment included returned to or, ng tube placed to evacuate excess air and fluid from colon, small bowel and stomach, staples and sutures removed to expose the mesh base, mesh was cut side to side and closed again with suture, presented to ed, hospitalized for one month, iv antibiotics, picc line, wound repacked, scheduled dressing changes, potassium repletion, aggressive irrigation of the wound, iv fluids, revision surgery, hernia repair with new mesh, and mesh removal.

• Brand Name: SURGIPRO
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 10292252
• MDR Text Key: 199448899
• Report Number: 9615742-2020-01658
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521101333
• UDI-Public: 10884521101333
• Combination Product (y/n): N
• PMA/PMN Number: K915526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2007
• Device Model Number: SPM-149
• Device Catalogue Number: SPM-149
• Device Lot Number: A2C211
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/17/2020
• Supplement Dates Manufacturer Received: 07/01/2020
• Supplement Dates FDA Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Weight: 120