MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,stu report with the FDA on 2017-02-10 for XENMATRIX AB 1151015 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[67208503]
A manufacturing review was performed and found that the lot was manufactured to specification. Seroma formation is a known inherent risk of any surgical procedure, the adverse reaction section of the ifu lists seroma as a potential complication of surgery. Based on the information provided, no conclusion can be made at this time. If additional information is provided, a supplemental mdr will be submitted. 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
[67208504]
It was reported to davol that a patient who is part of a clinical study experienced a post surgical site seroma. On (b)(6) 2016 - the patient underwent repair of a ventral hernia with implant of the xenmatrix ab graft. On (b)(6) 2016 - the patient was diagnosed with a subcutaneous seroma/old hematoma assessed as moderate severity and possibly related to the device and definitely related to the procedure. On (b)(6) 2017 - the patient had a bulge in the lower abdomen thought to be a hernia recurrence, however, ct scan confirmed this to be a large seroma and notes the hernia repair is intact. The patient underwent drainage of the seroma with a 12 f drain inserted into the anterior abdominal wall collection. This ae has been assessed by the study as possibly related to the device and definitely related to the procedure.
Patient Sequence No: 1, Text Type: D, B5
[72897763]
A review of the manufacturing records was performed and found that the lot was manufactured to specification. Seroma and infection are both known inherent risks of any surgical procedure, and are identified in the ifu as potential complications. Based on the patient? S reported clinical course it appears that she developed a post surgical seroma, which did not resolve when drained. It is likely, that due to the presence of a non resolving seroma an infection developed requiring additional intervention. It would appear that the patient condition is related to the procedure. However, no definitive conclusions can be made as to the degree to which the graft may have contributed to the patient outcome. Should any additional information be provided, a supplemental mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[72897764]
It was reported to davol that a patient who is part of a clinical study experienced a post surgical site seroma. On (b)(6) 2016 - the patient underwent repair of a ventral hernia with implant of the xenmatrix ab graft. On (b)(6) 2016 - the patient was diagnosed with a subcutaneous seroma/old hematoma assessed as moderate severity and possibly related to the device and definitely related to the procedure. On (b)(6) 2017 - the patient had a bulge in the lower abdomen thought to be a hernia recurrence, however, ct scan confirmed this to be a large seroma and notes the hernia repair is intact. The patient underwent drainage of the seroma with a 12 f drain inserted into the anterior abdominal wall collection. This ae has been assessed by the study as possibly related to the device and definitely related to the procedure. Addendum: this is an addendum to the previously submitted mdr as additional information has been provided regarding the patient's clinical course. This event is associated with xenmatrix ab study: (b)(6). On (b)(6) 2017 - the patient underwent the placement of an abdominal wound drain. On (b)(6) 2017 - the patient presented with ventral incision area swelling , redness and pain. The drain was removed. On (b)(6) 2017 - the patient was diagnosed with an abdominal wall abscess. The patient underwent an emergent incision and drainage. Purulent drainage was noted along with diagnosis of a superficial surgical site infection (ssi) and iv antibiotics were administered. Cultures were obtained which revealed bacterial growth of abundant staphylococcus aureus, abundant polys and gram positive cocci in pairs and clusters. On (b)(6) 2017- the patient was assessed to be stable and was discharged from the hospital. As reported the patient is recovering and the ae is resolving. This ae has been assessed by the study as possibly related to the device and definitely related to the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2017-00100 |
| MDR Report Key | 6324029 |
| Report Source | HEALTH PROFESSIONAL,OTHER,STU |
| Date Received | 2017-02-10 |
| Date of Report | 2017-04-05 |
| Date of Event | 2016-12-27 |
| Date Mfgr Received | 2017-03-14 |
| Device Manufacturer Date | 2016-02-18 |
| Date Added to Maude | 2017-02-10 |
| 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 BERG |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XENMATRIX AB |
| Generic Name | PORCINE SURGICAL MESH |
| Product Code | PIJ |
| Date Received | 2017-02-10 |
| Model Number | NA |
| Catalog Number | 1151015 |
| Lot Number | HUAN1400 |
| Device Expiration Date | 2018-01-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Hospitalization; 2. Required No Informationntervention | 2017-02-10 |