MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-01 for PHASIX MESH 1190300 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[143685123]
The cause of the patients reported post-op symptoms cannot be determined. No connection can be made between the reported events and the implant of the phasix mesh. A review of previous complaints 24 months found no similar complaints have been reported for the phasix mesh for an autoimmune reaction. A review of the manufacturing records was performed and found that the lot was manufactured to specification. Allergic reaction is listed in the adverse reaction section of the instructions-for-use as a possible complication. Should additional information be provided, a supplemental emdr will be submitted. Device evaluated by mfr: remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[143685124]
Physician (cardiologist) who is currently seeing a patient who has presented with suspected auto-immune type symptoms inquired about the phasix mesh and if there are any known cases in which this mesh has been involved in causing or contributing to auto-immune disorders such as lupus or raynaud' phenomenon. As reported, per physician: the patient underwent implant of a phasix mesh approximately 6 months ago. The patient has since developed symptoms closely related to those of reynaud's phenomenon. Doctor has described symptoms of vasoreactivity in which the fingers are reacting when exposed to warm temperatures (vs. Cold temperature). The patient's blood serology was negative for lupus and there has been no definitive diagnosis made at this time. Doctor states he cannot rule out the mesh as a contributing factor as the patient does not have a history of auto-immune disorders or allergies. The doctor was not interested in a surgeon to surgeon consult at this time, although this was offered. Doctor also did not want to pursue a mesh skin patch test as he stated he did not feel that would be beneficial in this particular case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2019-03535 |
| MDR Report Key | 8568689 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-01 |
| Date of Report | 2019-05-01 |
| Date Mfgr Received | 2019-04-12 |
| Device Manufacturer Date | 2017-11-11 |
| Date Added to Maude | 2019-05-01 |
| 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 | 2019-05-01 |
| Model Number | NA |
| Catalog Number | 1190300 |
| Lot Number | HUBV0042 |
| Device Expiration Date | 2019-08-28 |
| 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 | 2019-05-01 |