FDA Adverse Event
Death
Summary report: N
DURAMATRIX SUTURABLE
MDR report key: 15125092
·
Received July 28, 2022
Report
- Report Number
- 2249852-2022-00023
- Event Type
- Death
- Date Received
- July 28, 2022
- Report Date
- October 27, 2022
- Manufacturer
- COLLAGEN MATRIX, INC
- Product Code
- GXQ
- PMA / PMN Number
- K141608
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL QUALITY CONTROL TESTING OF SAMPLES IS PENDING.
Additional Manufacturer Narrative · 0
ADDITIONAL QUALITY CONTROL TESTING SHOWED THE PRODUCT MET ACCEPTABLE STERILITY, ENDOTOXIN, AND PH CRITERIA.
Description of Event or Problem · 0
LIMITED INFORMATION FROM A CLINICAL DATA COLLECTION SITE REPORTED AFTER USING THE DURAMATRIX SUTURABLE, THE PATIENT DEVELOPED A INTRAPARENCHYMAL HEMATOMA IMMEDIATELY POST-OP. THE DURAMATRIX SUTURABLE WAS REMOVED IN A SECOND SURGERY TO EVACUATE THE HEMATOMA. THE PATIENT HAD L FRONTAL HIGH GRADE GLIOMA, DEVELOPED A BLEED, AND EXPIRED. DATE OF PATIENT DEATH WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2458166 | DURAMATRIX SUTURABLE | COLLAGEN DURA MEMBRANE | GXQ | COLLAGEN MATRIX, INC | 1912211121 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other| D| R |