inforMED
InjuryNPK

MEMBRAGEL

Received Jan 6, 2012 · Event occurred Oct 12, 2011

Report 1222315-2012-00003 · MDR key 2406186

Device

Generic name

Product Code Npk - Barrier Membrane

Catalog number

070.101

Lot number

Z5927

Product problems

  • Device Operates Differently Than Expected

Patient

54 YR

  • Purulent Discharge
  • Hemorrhage/Blood Loss/Bleeding
  • Inflammation
  • Pain
  • Swelling
  • Discomfort
  • Foreign Body In Patient

Narrative

Description of Event or Problem

BUCCAL BONE AUGMENTATION ONLY WITHOUT IMPLANTATION ON (B)(6) 2011; REGIO 42 USING BONE CERAMIC AND MEMBRAGEL. PERIO CUT / AREA CLOSURE STRESS-FREE. (B)(6) 2011 CONTROL VISIT: NICE SITUATION / NO PAIN ONLY STRANGE FEELING. (B)(6), 2011: STILL SOME PAIN / NICE HEALING WITHOUT SWELLING / SOME PAIN UNDER PRESSURE / NO LIQUID SECRETION UNDER PRESSURE. (B)(6) 2011 CONTROL VISIT : GINGIVA AREA 43 SOME INFLAMMATION / A LOT OF PLAQUE / CLEANING / NO PUS / REMOVAL OF LITTLE PIECES (MEMBRAGEL?). (B)(6) 2011 CONTROL VISIT: LESS PAIN / PUS WITH AND WITHOUT PRESSURE =>> REMOVAL. (B)(6) 2011 REMOVAL / EMDOGAIN REGIO 42 / A LOT OF PUS / PAINFUL / EXTREME INFLAMMATION / STRONG BLEEDING / REMOVAL MEMBRAGEL AND BONECERAMIC / CLEANING AND RINSED WITH NACL. (B)(6) 2011 NICE WOUND HEALING / SUTURE REMOVAL / SUBSEQUENT TREATMENT OK.

Additional Manufacturer Narrative

THE BATCH RECORD REVIEW HAS BEEN CARRIED OUT AND CONFIRMS THAT THE PRODUCT WAS WITHIN SPECIFICATION.