MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-11 for PHASIX MESH UNKAA091 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[129962152]
Per the surgeon the cause of the postoperative infection is most likely related to the mesh being placed in a contaminated environment. However, a definitive conclusion cannot be made. No lot number has been provided; therefore a review of the manufacturing records could not be conducted. Note, the date of implant is estimated as only the month/year were provided. Should additional information be provided, a supplemental emdr will be submitted. Note: remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[129962153]
It was reported that in (b)(6) 2018 the patient underwent the repair of multiple ventral hernias and a colostomy reversal procedure and was implanted with a bard phasix mesh as an underlay. As reported, postoperatively, the patient developed an infection above the fascia and had a surgical drain placed to remove the fluid. The surgeon reported he believes the cause of the infection was due to the mesh being placed in a highly contaminated area involving the colon (colostomy reversal). The surgeon stated he is not planning to remove any of the mesh and is going to allow for the mesh to resorb. The patient is being treated with antibiotics at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2018-04584 |
| MDR Report Key | 8152359 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-11 |
| Date of Report | 2018-12-11 |
| Date Mfgr Received | 2018-11-20 |
| Date Added to Maude | 2018-12-11 |
| 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 | 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 MESH |
| Generic Name | SURGICAL MESH |
| Product Code | OOD |
| Date Received | 2018-12-11 |
| Model Number | NA |
| Catalog Number | UNKAA091 |
| Lot Number | NI |
| 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 | 2018-12-11 |