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 2017-02-13 for XENMATRIX AB 1152020 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[67248014]
Seroma formation is a known inherent risk of any surgical procedure 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. Based on the information provide, the patient developed a post operative seroma which was drained and has not recurred. The study md has assessed the seroma to be possibly related to the study device and definitely related to the procedure. No definitive 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
[67248015]
It was reported to davol that a patient who is part of a clinical study experienced a post operative seroma. On (b)(6) 2016 - the patient underwent the repair of a recurrent ventral incisional hernia with bilateral posterior component separation, bilateral transverse abdominus release, placement of a bard xenmatrix ab graft, removal of retained gallbladder tissue and gallstones. On (b)(6) 2017 - the patient called the study md with complaints of pain at the incision site of a prior drain and stated the pain was "pulsing" and severe, however, did not radiate. The patient stated that the pain was not alleviated 1 hour after taking oxycodone. The patient presented to his local hospital and underwent aspiration of a fluid collection (seroma). The fluid was reported to have not been infected. On (b)(6) 2017 - the patient presented for 6 week post op visit and states that there had been no recurrence of the fluid collection. The patient had no other complaints. The study md has assessed the seroma to be possibly related to the study device and definitely related to the procedure.
Patient Sequence No: 1, Text Type: D, B5
[74186954]
This is an addendum to the initial mdr to document additional medical treatment provided to the patient. This treatment was reported to be associated to a cascading event stemming from the previously reported seroma. The study md has assessed this event to be possibly related to the study device and definitely related to the procedure. No definitive conclusion can be made at this time. If additional information is provided, a supplemental mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[74186955]
It was reported to davol that a patient who is part of a clinical study experienced a post operative seroma. On (b)(6) 2016 - the patient underwent the repair of a recurrent ventral incisional hernia with bilateral posterior component separation, bilateral transverse abdominus release, placement of a bard xenmatrix ab graft, removal of retained gallbladder tissue and gallstones. On (b)(6) 2017 - the patient called the study md with complaints of pain at the incision site of a prior drain and stated the pain was "pulsing" and severe, however, did not radiate. The patient stated that the pain was not alleviated 1 hour after taking oxycodone. The patient presented to his local hospital and underwent aspiration of a fluid collection (seroma). The fluid was reported to have not been infected. On (b)(6) 2017 - the patient presented for 6 week post op visit and states that there had been no recurrence of the fluid collection. The patient had no other complaints. The study md has assessed the seroma to be possibly related to the study device and definitely related to the procedure. This is an addendum to the initial mdr. On (b)(6) 2017 - the patient presented for three month follow up visit with report that the inferior aspect of his midline incision has opened up since the aspiration of his seroma. It occasionally drains some serosanguinous fluid. Upon exam the md notes the midline incision is mostly healed with inferior opening due to epithelialized tract from prior seroma, no erythema (some irritation from tape), no warmth, minimal serosanguinous drainage with no evidence of hernia recurrence. Patient will follow up with a wound clinic for twice weekly silver nitrate applications with wound packing until it has healed. Surgeon assessed this event as a grade 1 clinical severity, not serious, possibly related to the device and definitely related to the procedure. The study notes there was no intervention required and the patient is recovering.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2017-00101 |
| MDR Report Key | 6325558 |
| Report Source | HEALTH PROFESSIONAL,OTHER,STU |
| Date Received | 2017-02-13 |
| Date of Report | 2017-04-20 |
| Date of Event | 2017-01-05 |
| Date Mfgr Received | 2017-03-27 |
| Device Manufacturer Date | 2016-06-24 |
| Date Added to Maude | 2017-02-13 |
| 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 | 2017-02-13 |
| Model Number | NA |
| Catalog Number | 1152020 |
| Lot Number | HUAS0662 |
| Device Expiration Date | 2018-05-31 |
| 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. Required No Informationntervention | 2017-02-13 |