MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-06-26 for PHASIX MESH UNKAA091 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[112382266]
Based on the information provided we are unable to determine to what extent, if any, the phasix mesh may have caused or contributed to the alleged infection. While the surgeon has alleged that the infection is related to the mesh, based on the information provided no conclusion can be made. Multiple attempts have been made to obtain additional information. However, to date only limited information is available. Infection is a known inherent risk of surgery. Regarding infection the warning section of the instructions-for-use states, "if an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the mesh. An unresolved infection may require removal of the device. " a lot number was not provided; without a lot number a review of the manufacturing records is not possible. Note the date of implant is an estimate as the contact did not know the exact date, however stated that it was approximately 18 months ago. Additionally, the date of event/explant date is an estimate as an exact date of the revision surgery was not provided. Should additional information be obtained, a supplemental emdr will be submitted. Note: the information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. Not returned.
Patient Sequence No: 1, Text Type: N, H10
[112382267]
As reported approximately 18 months ago the patient was implanted with a phasix mesh. As alleged the patient developed an infection related to the mesh. In (b)(6) 2018 the patient underwent a procedure to remove some of the mesh due to the infection. As reported some mesh was left behind. The patient is currently being treated with antibiotics. The reporting facility is not the facility or surgeon that implanted the mesh and as reported the exact date of implant and product identifiers are unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2018-02212 |
| MDR Report Key | 7639343 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-06-26 |
| Date of Report | 2018-06-26 |
| Date of Event | 2018-04-15 |
| Date Mfgr Received | 2018-06-08 |
| Date Added to Maude | 2018-06-26 |
| 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 | 2018-06-26 |
| 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 | 2018-06-26 |