MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-20 for INTEGRA BOVINE PERICARDIUM DURAL GRAFT BP10812 manufactured by Tutogen Medical Gmbh.
[68485617]
Pt had craniotomy on (b)(6) 2016, with dural implanted and returned to operating room on (b)(6) 2017 for intracranial infection. Operation: left craniectomy, debridement of subdural empyema. Findings: purulent material in the subdural space. Bone flap, fixation clips and dural graft removed, cultures taken. On (b)(6) 2017, culture results:. Anaerobic culture duragen patch from tissue/head. Positive propionibacterium acnes anaerobic culture left bone flap from bone/head. Positive propionibacterium acnes anaerobic culture from subdural fluid 1 from tissue/head. Positive head: positive propionibacterium acnes tissue culture and smear and anaerobic culture from subdural fluid 2 from tissue/head. Positive propionibacterium acnes tissue. Culture and smear from duragen patch from graft/head. Positive staphylococcus coagulase negative bone culture and smear from left bone/head. Positive staphylococcus capitis tissue culture and smear from subdural fluid 1 tissue/head. Positive propionibacterium granulosum. On (b)(6) 2016, operation - left frontocentroparietal craniotomy excision of meningioma. Implanted dural graft and fixation clips. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW5068140 |
MDR Report Key | 6360798 |
Date Received | 2017-02-20 |
Date of Report | 2017-02-20 |
Date of Event | 2017-01-25 |
Date Added to Maude | 2017-02-27 |
Event Key | 0 |
Report Source Code | Voluntary report |
Manufacturer Link | N |
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 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | INTEGRA BOVINE PERICARDIUM DURAL GRAFT |
Generic Name | DURAL GRAFT |
Product Code | GXQ |
Date Received | 2017-02-20 |
Catalog Number | BP10812 |
Lot Number | 000000013380389 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | TUTOGEN MEDICAL GMBH |
Manufacturer Address | NEUNKIRCHEN A. BR. 91077DE 91077 DE |
Brand Name | TITANIUM CLAMP CRANIOFIX 2 |
Generic Name | TITANIUM CLAMP |
Product Code | GDJ |
Date Received | 2017-02-20 |
Lot Number | 52246501 |
Device Availability | * |
Device Eval'ed by Mfgr | I |
Device Sequence No | 2 |
Device Event Key | 0 |
Manufacturer | AESCULAP/B. BRAUN |
Brand Name | TITANIUM CLAMP CRANIOFIX 2 |
Generic Name | TITANIUM CLAMP |
Product Code | GDJ |
Date Received | 2017-02-20 |
Lot Number | 52187756 |
Device Availability | * |
Device Eval'ed by Mfgr | I |
Device Sequence No | 3 |
Device Event Key | 0 |
Manufacturer | AESCULAP/B. BRAUN |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2017-02-20 |