MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-02-11 for ARISTA AH ABSORBABLE HEMOSTAT SM0002 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[188797619]
Based on the limited information provided, no definitive conclusion can be made. The cause of the alleged adhesions cannot be determined at this time. As reported, the excess arista product was not removed from the site of application by irrigation and/or aspiration. Our instructions for use (ifu) identifies that excess arista ah should be removed for the site of application by irrigation and aspiration. The possibility of the product interfering with normal function and/or causing compression necrosis of surrounding tissue due to swelling is reduced by removal of excess dry material. A review of the manufacturing records was performed for the subject lot and found that the lot was manufactured to specification. To date, this is the only reported complaint for the subject lot of (b)(4) units manufactured in june of 2019. Used in patient.
Patient Sequence No: 1, Text Type: N, H10
[188797620]
It was reported that two days after a laparoscopic hysterectomy case, the patient was vomiting and in severe pain. Patient was taken back to theatre and adhesions in the area were discovered and removed. It was reported that a full 3g bellow of arista was used during the procedure and the excess product was not removed from the site of application by irrigation and/or aspiration. The surgeon believes there is a correlation between the patient's adhesion formation and the arista product applied.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2020-01102 |
| MDR Report Key | 9696239 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-02-11 |
| Date of Report | 2020-02-11 |
| Date of Event | 2019-12-17 |
| Date Mfgr Received | 2020-01-24 |
| Device Manufacturer Date | 2019-06-19 |
| Date Added to Maude | 2020-02-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANNA SMITH |
| Manufacturer Street | 100 CROSSINGS BLVD. |
| Manufacturer City | WARWICK RI 02886 |
| Manufacturer Country | US |
| Manufacturer Postal | 02886 |
| Manufacturer Phone | 4018258449 |
| Manufacturer G1 | DAVOL INC. - 1223089 |
| Manufacturer Street | 160 NEW BOSTON STREET |
| Manufacturer City | WOBURN MA 01801 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARISTA AH ABSORBABLE HEMOSTAT |
| Generic Name | AGENT, ABSORBABLE HEMOSTATIC, NON COLLAGEN BASED |
| Product Code | LMG |
| Date Received | 2020-02-11 |
| Model Number | NA |
| Catalog Number | SM0002 |
| Lot Number | 6101401 |
| 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 | 2020-02-11 |