MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-07 for PHASIX MESH UNKAA091 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[138128377]
No conclusion can be made. Based on the information provided at this time no conclusion can be made as to the degree to which the bard phasix mesh may be causing or contributing to the patient's reported rash. A mesh sample has been provided to the patient's doctor for reactivity testing. At this time the testing has not been completed. We have requested to be updated on the patient's status and test results when available. A lot number has not been provided; therefore a review of the manufacturing records could not be conducted. The adverse reactions section of the instructions-for-use identifies allergic reaction as a possible complication. Should additional information be provided, a supplemental emdr will be submitted. Remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[138128378]
It was reported that approximately one month post implant of a bard phasix mesh the patient developed a systemic rash on the trunk and extremities. The patient has been treated with intramuscular kenalog injection and triamcinolone cream. The patient doctor has requested a mesh sample for reactivity testing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2019-01413 |
| MDR Report Key | 8400403 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-07 |
| Date of Report | 2019-03-07 |
| Date Mfgr Received | 2019-02-15 |
| Date Added to Maude | 2019-03-07 |
| 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 MESH |
| Generic Name | SURGICAL MESH |
| Product Code | OOD |
| Date Received | 2019-03-07 |
| 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 | 2019-03-07 |