FDA Adverse Event
Injury
Summary report: N
MEMBRAGEL
MDR report key: 2251463
·
Received September 14, 2011
Report
- Report Number
- 1222315-2011-00036
- Event Type
- Injury
- Date Received
- September 14, 2011
- Date of Event
- August 15, 2011
- Report Date
- September 14, 2011
- Manufacturer
- INSTITUT STRAUMANN AG
- Product Code
- NPK
- PMA / PMN Number
- K101956
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
THE BATCH RECORD REVIEW HAS BEEN CARRIED OUT AND CONFIRMS THAT THE PRODUCT WAS MFG AND RELEASED ACCORDING TO SPECS.
Description of Event or Problem · 1
IMPLANTATION OF IMPLANT ARTICLE NUMBER 033.653S, LOT AK316 WITH RIDGE AUGMENTATION USING BIOOSS (B)(4), LOT 11033 AND MEMBRAGEL 0.8 ML LOT AN688 ON (B)(6), 2011. ONLY THE AUGMENTATION MATERIAL WAS REMOVED ON (B)(6), 2011. THE IMPLANT WAS STABLE. CLINICIAN REPORTS THAT THE PT HAD PAIN AND SWELLING INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEMBRAGEL | BARRIER MEMBRANE | NPK | INSTITUT STRAUMANN AG | AN688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |