MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-30 for PHASIX MESH 1191025 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[143558052]
Based on the information provided no conclusion can be made. The information provided is limited. Multiple attempts have been made requesting additional information. Hematoma formation and wound dehiscence are known inherent risks of surgery and are identified in the adverse reaction section of the instructions-for-use as possible complications. A review of the manufacturing 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
[143558053]
It was reported that on (b)(6) 2019 the patient was implanted with a bard/davol phasix mesh. Postoperatively the patient developed a hematoma and wound dehiscence. The surgeon requested a surgeon to surgeon consult, which was granted and negative pressure wound therapy (npwt) was recommended to treat the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2019-03503 |
| MDR Report Key | 8564891 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-30 |
| Date of Report | 2019-04-30 |
| Date Mfgr Received | 2019-04-10 |
| Device Manufacturer Date | 2017-06-15 |
| Date Added to Maude | 2019-04-30 |
| 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 | 2019-04-30 |
| Model Number | NA |
| Catalog Number | 1191025 |
| Lot Number | HUBS0193 |
| Device Expiration Date | 2019-05-28 |
| 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 | 2019-04-30 |