MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-23 for PHASIX ST W/ OPS 1220011 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[184445748]
As reported early postoperative adhesions occurred. The sample was not provided for evaluation. Photos were provided showing both sides of the mesh post explant, and also a photo of the distended bowel and dilated bowel. Review of the photos did not assist in determining a root cause for the postoperative adhesions and obstruction. As reported the mesh was not hydrated prior to implant as prescribed in the instructions-for-use, it is unclear if this may have contributed to the postoperative adhesions and obstruction. Based on the information provided and photo evaluation, no conclusion can be made. The instructions-for-use states, "hydration of the device for 1-3 seconds is recommended. " and "deviation from recommended instructions and/or procedural steps within this ifu may result in disruption or delamination of the hydrogel barrier of the mesh. Hydrogel disruption or delamination may cause an unexpected increase in adhesion formation in the area where it is disrupted. " adhesion formation is a known inherent risk of surgery and is listed in the adverse reaction section of the ifu as a possible complication. To date this is the only reported complaint for this production lot of (b)(4) units released for distribution in july, 2019. A review of the manufacturing records was performed and found that the lot was manufactured to specification. Not returned.
Patient Sequence No: 1, Text Type: N, H10
[184445749]
It was reported that on (b)(6) 2020 the patient was implanted intra-abdominally with a bard phasix st mesh (ops) during an open umbilical hernia repair procedure. As reported the mesh was not hydrated prior to implant. The sepra (st) barrier was properly oriented toward the bowel with the mesh side toward the abdominal wall. On (b)(6) 2020 due to an obstruction the patient was bought back to the or and underwent explant of the mesh. Dense adhesions to the mesh were reported. The doctor noted that in a photo taken of the bowel you can "clearly see where the distended bowel and dilated bowel are that caused the obstruction and in the center you can see the left behind seprafilm from the mesh. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2020-02800 |
| MDR Report Key | 9864835 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-07-11 |
| Date Added to Maude | 2020-03-23 |
| 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 ST W/ OPS |
| Generic Name | SURGICAL MESH |
| Product Code | OWT |
| Date Received | 2020-03-23 |
| Model Number | NA |
| Catalog Number | 1220011 |
| Lot Number | HUDR0705 |
| 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 | 2020-03-23 |