SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH MESH, SURGICAL, POLYMERIC
|
Back to Search Results |
|
Model Number PCO2520X |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
|
Patient Problems
Abdominal Pain (1685); Abscess (1690); Hematoma (1884); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Perforation (2001); Sepsis (2067); Seroma (2069); Swelling (2091); Tachycardia (2095); Ulcer (2274); Injury (2348); Ambulation Difficulties (2544); Blood Loss (2597); No Code Available (3191); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); 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 an incarcerated ventral hernia.
It was reported that after implant, the patient experienced perforation, tachycardia, hypotension, sepsis, acute kidney injury, abnormal coagulation, abdominal pain and swelling, difficulty walking, and physical pain and gastrointestinal bleeding.
Post-operative patient treatment included revision surgery.
On (b)(6) 2014 - a previous admission the patient was admitted and was diagnosed with gastritis, gastroparesis and diabetes and ultimately discharged.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
Evaluation summary: to date, the incident sample has not been received for evaluation.
If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.
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 diagnosis was a perforated duodenal ulcer.
The procedure performed was an exploratory laparotomy for primary repair of duodenal perforation and omental patch.
|
|
Search Alerts/Recalls
|
|
|