MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-01-31 for PHASIX ST MESH 1203035 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[177379319]
Based on the available information no conclusion can be made. A review of the manufacturing records was performed and found that the lot was manufactured to specification. To date this is the only reported complaint for this production lot of 33 units released for distribution in june, 2019. Adhesion formation and infection are known inherent risks of surgery and are listed in the adverse reactions section of the instructions-for-use as possible complications. Additionally, the instructions-for-use was found to instruct the user in multiple locations of the importance of proper orientation of the device. The warning section states, "ensure proper orientation; the coated side of the prosthesis should be oriented against the bowel or sensitive organs. Do not place the uncoated mesh side against the bowel. There is a risk for adhesion formation or erosions when the uncoated mesh side is placed in direct contact with the bowel or viscera. " the surgeon reported the device was placed in the correct orientation. The implant was reported to not have incorporated with tissue ingrowth during the time in vivo. The cause cannot be determined. Should additional information be provided, a supplemental emdr will be submitted. Not returned.
Patient Sequence No: 1, Text Type: N, H10
[177379320]
It was reported that a patient who had previously been implanted with a bard phasix st mesh underwent an additional procedure due to intestinal adhesions to the mesh. As reported the surgeon "had to cut the intestine spot and perform an anastomosis. " a biopsy was performed and indicated enterococci. As reported the patient is "still at risk. " the surgeon reports that the mesh was implanted correctly, with the? Smooth side? (internal side) down. The material was affixed (adhered) to the intestine and it perforated it, while the? Top side? (external side) had no tissue growth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2020-00774 |
| MDR Report Key | 9652587 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-01-31 |
| Date of Report | 2020-02-13 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2019-06-27 |
| Date Added to Maude | 2020-01-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LAURA SUNDBERG |
| Manufacturer Street | 100 CROSSINGS BLVD. |
| Manufacturer City | WARWICK RI 02886 |
| Manufacturer Country | US |
| Manufacturer Postal | 02886 |
| Manufacturer Phone | 4018258462 |
| 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 ST MESH |
| Generic Name | SURGICAL MESH |
| Product Code | OWT |
| Date Received | 2020-01-31 |
| Model Number | NA |
| Catalog Number | 1203035 |
| Lot Number | HUDP2065 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DAVOL INC., SUB. C.R. BARD, INC. |
| Manufacturer Address | 100 CROSSINGS BLVD. WARWICK RI 02886 US 02886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2020-01-31 |