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 1152020 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[67174607]
A manufacturing review that included a review of sterility records was performed and found that the lot was manufactured to specification. Infection is a known inherent risk of any surgical procedure, the warning section of the ifu states, "this device is not indicated for the treatment of infection. If an infection develops, treat the infection aggressively. " the adverse reaction section lists seroma and infection as potential complications. Based on the information provided, no conclusion can be made at this time. Treatment is ongoing 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
[67174608]
It was reported to davol that a patient who is part of a clinical study experienced a post surgical site infection. On (b)(6) 2016 - the patient underwent repair of a recurrent hernia, with implant of the xenmatrix ab with posterior component separation. On (b)(6) 2017 - the patient was diagnosed with a surgical site infection in the deep tissue layer with purulent drainage from deep within the incision. On (b)(6) 2017 - the patient presented to the er with complaints of abdominal pain in the lower abdomen and associated with distention. The patient is noted to have had nausea, vomiting and diarrhea. A urine analysis showed ecoli bacteria in which she was treated with antibiotics. On (b)(6) 2017 - the patient presented with possible seroma under the skin and cellulitis. Two surgical drains were placed in the retro-rectus space in the left lower quadrant. This ae has been assessed by the study as possibly related to the device and definitely related to the procedure and has been considered a severe ae requiring intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2017-00099 |
| MDR Report Key | 6323586 |
| Report Source | HEALTH PROFESSIONAL,OTHER,STU |
| Date Received | 2017-02-10 |
| Date of Report | 2017-02-10 |
| Date of Event | 2017-01-15 |
| Date Mfgr Received | 2017-01-26 |
| Device Manufacturer Date | 2015-09-30 |
| 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 | 1152020 |
| Lot Number | HUZH0398 |
| Device Expiration Date | 2017-08-28 |
| 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. Hospitalization; 2. Required No Informationntervention | 2017-02-10 |