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 2018-05-22 for PHASIX MESH 1190500 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[109010579]
The sample evaluation of the returned mesh confirms for the reported condition of torn mesh. The mesh had been tailored by the user to create an l shape. In the corner of the l shape there is a tear where two edges were created when tailoring the mesh. This appears to be where the surgeon attempted to place a suture. There is no evidence of suture material left on the mesh, but it appears likely that the suture pulled out of the mesh as reported causing the damage noted. It is unknown if creating this l shape caused damaged to the mesh at the angle of the l before the user attempted to place the suture. The mesh is stretched in the area of the tear further indicating a pull force was applied to this area of the mesh. Visual examination of the mesh under magnification found no manufacturing anomalies with the material. It appears that the damage was related to force applied to the mesh and not due to material condition. Based on the available information and product evaluation it can be reasonably determined that forces applied to the mesh during attempted fixation caused the issue that presented. To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in (b)(6) 2017. 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. All process steps were completed per manufacturing and inspection procedures. Product passed all required inspections at both end product and subassembly levels. There was no rework or other manufacturing abnormalities that may have contributed to this complaint. 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.
Patient Sequence No: 1, Text Type: N, H10
[109010580]
It was reported that on (b)(6) 2018 during a "diep flap" (breast reconstruction) procedure while attempting to fixate a customized bd surgery / davol phasix mesh, the surgeon used a 0-maxon suture on a tapered needle and placed the suture about 1 cm from the mesh edge which reportedly would not hold the suture and tore the mesh. The phasix mesh was removed and the surgeon used an unspecified monofilament polypropylene flat mesh to complete the case. As reported, there was no patient injury or harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2018-01627 |
| MDR Report Key | 7534594 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-05-22 |
| Date of Report | 2018-05-22 |
| Date of Event | 2018-05-02 |
| Date Mfgr Received | 2018-05-02 |
| Device Manufacturer Date | 2017-12-27 |
| Date Added to Maude | 2018-05-22 |
| 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 | 2018-05-22 |
| Returned To Mfg | 2018-05-11 |
| Model Number | NA |
| Catalog Number | 1190500 |
| Lot Number | HUBW0165 |
| Device Expiration Date | 2019-11-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-05-22 |