MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-07 for PHASIX ST MESH 1201520 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[144317594]
No conclusion can be made. Based on the information provided we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as reported. Bard/davol products are provided to the customer in a sterile state. At this time the patient is recovering at home, with no additional reported complications. Infection and seroma are known inherent risks of any surgical procedure and are identified in the adverse reactions section of the instructions-for-use as possible complications. A manufacturing review that included review of sterility records was performed and found that the lot was manufactured to specification should additional information be provided, a supplemental emdr will be submitted. Remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[144317595]
It was reported that in (b)(6) 2019 the patient was implanted with a bard/davol phasix st mesh during an abdominal wall repair procedure. Postoperatively the patient was treated with antibiotics for a possible infection. The surgeon requested a surgeon to surgeon consult regarding the patient's treatment. The surgeon reports that she was satisfied with the treatment plan that was discussed during the consult. As reported the surgeon will continue to treat the patient with antibiotics throughout this time. Currently the wound is closed and the patient is recovering from the surgery in her home. Also reported was fluid build up, it is unclear if this is a seroma, or extra fluid from the resorption of the st barrier, which is not uncommon in the postoperative time period.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2019-03658 |
| MDR Report Key | 8587927 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-07 |
| Date of Report | 2019-05-07 |
| Date Mfgr Received | 2019-04-18 |
| Device Manufacturer Date | 2018-12-21 |
| Date Added to Maude | 2019-05-07 |
| 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 | 2019-05-07 |
| Model Number | NA |
| Catalog Number | 1201520 |
| Lot Number | HUCX1935 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Required No Informationntervention | 2019-05-07 |