Undesirable Effects

Serious adverse reactions including neurotoxicity (vertigo, tinnitus), ototoxicity (potential hearing loss, deafness, balance loss) and nephrotoxicity have occurred primarily in patients receiving systemic gentamicin therapy. However, systemic absorption following implantation of Collatamp G is unlikely to constitute a comparable risk.¹

Rare / very rare incidents (maximum 1 incident by sales volume of 10,000 qty.) potentially associated with Collatamp G use include delayed/impaired wound healing, local infection / secretion, haematoma, seroma, elevated creatinine levels, sensitisation/hypersensitivity reactions, and thrombosis. Categories and ranges have been calculated based on `probability of occurrence’ estimates using the manufacturer’s risk management rating system. As a reference parameter, the probability of occurrence of an ´event per patient´ is used, which is based on product sales numbers.¹