MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2018-10-23 for PHASIX MESH 1190500 manufactured by Bard Shannon Limited -3005636544.
[124686861]
Based on the information received, there is no way to determine whether the bard/davol phasix mesh (device #2) may have caused or contributed to the problems experienced due to the patient's complex medical/surgical history. No conclusions can be made. This emdr represents the bard/davol phasix mesh (device #2). An additional emdr was submitted to represent the bard/davol composix kugel hernia patch (device #1). Should additional information be provided a supplemental emdr will be submitted. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[124686862]
Information reported via patient's attorney and medical records: (b)(6) 2004: the patient underwent an unspecified abd procedure with implant of a bard/davol composix kugel hernia patch (device #1) and a non bard/davol? Prolene? Mesh. About 9 years later the patient developed an abd wall abscess and cellulitis. In (b)(6) 2012 the patient underwent an incision and drainage procedure of the abd wall abscess. On (b)(6) 2013: the patient underwent incision and drainage of abd wall abscess with debridement of abd wall, removal of infected prosthetic mesh, small bowel resection with primary anastomosis, repair of abd wall hernia with implant of a non bard/davol? Vicryl? Mesh. On (b)(6) 2013: the patient was diagnosed with a recurrent incisional ventral hernia repair with implant of a bard/davol phasix mesh (device #2), explant of the non bard/davol? Vicryl? Mesh, bilat myocutaneous flaps utilizing separation components procedure, small bowel resection and extensive lysis of adhesions. Per the operative report details,? We then were able to close the midline with looped pds and then place a 25 x 30 cm phasix mesh.? Between (b)(6) 2013 the patient was hospitalized for sepsis shock and an abd wound infection with (b)(6) bacteria. Patient was treated medically and discharged home with healthcare services. Between (b)(6) 2013 the patient was found hypotensive and was transferred to another hospital for septic shock management. Between (b)(6) 2014 the patient was hospitalized for a left carotid subclavian bypass.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2018-03662 |
| MDR Report Key | 7994940 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2018-10-23 |
| Date of Report | 2018-10-23 |
| Date of Event | 2013-11-12 |
| Date Mfgr Received | 2018-10-17 |
| Date Added to Maude | 2018-10-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | FRANCESCA SANTAMARIA |
| Manufacturer Street | 100 CROSSINGS BLVD. |
| Manufacturer City | WARWICK RI 02886 |
| Manufacturer Country | US |
| Manufacturer Postal | 02886 |
| Manufacturer Phone | 4018258538 |
| Manufacturer G1 | BARD SHANNON LIMITED -3005636544 |
| Manufacturer Street | SAN GERONIMO INDUSTRIAL PARK LOT #1, ROAD #3, KM 79.7 |
| Manufacturer City | HUMACAO PR 00791 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00791 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHASIX MESH |
| Generic Name | SURGICAL MESH |
| Product Code | OOD |
| Date Received | 2018-10-23 |
| Model Number | NA |
| Catalog Number | 1190500 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD SHANNON LIMITED -3005636544 |
| Manufacturer Address | SAN GERONIMO INDUSTRIAL PARK LOT #1, ROAD #3, KM 79.7 HUMACAO PR 00791 US 00791 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2018-10-23 |