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 2017-04-05 for XENMATRIX AB 1151928 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[71749303]
Based on the information provided, at this time, no conclusion can be made as to the degree to which the xenmatrix ab graft may have caused or contributed to the post surgical seroma. Seroma formation is a known inherent risk with the use of any prosthesis, and is identified in the adverse reaction section of the ifu as a potential complication. A review of the manufacturing records was performed and found that the lot was manufactured to specification. 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. Device remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[71749304]
The following was reported and is associated with clinical study (b)(4): (b)(6) 2016 - the patient was implanted with a bard xenmatrix ab. (b)(6) 2017 - the patient seen for a follow up visit. During this visit, a previously performed ct scan was reviewed and showed a superficial lower left abdominal seroma. The patient was scheduled for an open incision and drainage. The seroma is assessed as mild severity, grade iii, possibly related to the device and definitely related to the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2017-00212 |
| MDR Report Key | 6460841 |
| Report Source | HEALTH PROFESSIONAL,OTHER,STU |
| Date Received | 2017-04-05 |
| Date of Report | 2017-04-05 |
| Date of Event | 2017-03-09 |
| Date Mfgr Received | 2017-03-10 |
| Device Manufacturer Date | 2015-09-15 |
| Date Added to Maude | 2017-04-05 |
| 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 | SURGICAL MESH |
| Product Code | PIJ |
| Date Received | 2017-04-05 |
| Model Number | NA |
| Catalog Number | 1151928 |
| Lot Number | HUZH0395 |
| Device Expiration Date | 2017-07-28 |
| 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 | 2017-04-05 |