MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2018-06-08 for PHASIX MESH 1190500 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[110454761]
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 patient's post operative complications. At this time no conclusions can be made. Pain and inflammation are listed in the adverse reaction section of the instructions-for-use as possible complications. A review of the manufacturing records was performed. No manufacturing issues associated to the reported event were found in the reviewed lot. Dhr review showed component acceptability and traceability were confirmed through incoming inspection records for traceable components used. All process steps were completed per manufacturing and inspection procedures. Product passed all required inspections at each step at end product level. There was no rework or other manufacturing abnormalities that may have contributed to this complaint. Should additional information be provided, 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. Remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[110454762]
The following is associated with a patient who is part of a clinical study: on (b)(6) 2017 - the patient underwent the repair of a primary incisional midline hernia with multiple midline defects and was implanted with a phasix mesh. A retro-rectus with component separation technique (posterior technique) was performed. The hernia defect measured 14cm in length and 4cm in width with swiss cheese configuration and multiple discreet hernias. The hernia site was assessed as clean contaminated and classified as vhwg grade 3 due to take down of ileostomy with ileocolonic anastomosis and created of a stoma. The mesh was fixated with 6 fixation points using mechanical fixation. On (b)(6) 2018 - the patient was diagnosed with chronic inflammation and fasciitis on the underlying mesh. This ae has been assessed by the clinician as mild in severity, possibly related to the device and possibly related to the procedure. The patient was sent for a ct scan of the abdomen and a consultation with a pain therapist. This condition is ongoing and will be re-evaluated at a later date by the clinician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2018-01860 |
| MDR Report Key | 7581731 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2018-06-08 |
| Date of Report | 2018-06-08 |
| Date of Event | 2018-03-22 |
| Date Mfgr Received | 2018-05-14 |
| Device Manufacturer Date | 2016-10-21 |
| Date Added to Maude | 2018-06-08 |
| 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 | 2018-06-08 |
| Model Number | NA |
| Catalog Number | 1190500 |
| Lot Number | HUAV0563 |
| Device Expiration Date | 2018-09-28 |
| 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 | 2018-06-08 |