InjuryIOY
PROCARE
Received Nov 5, 2014 · Event occurred Aug 26, 2014
Report 9616086-2014-00018 · MDR key 4241129
Product problems
- Patient-Device Incompatibility
Patient
Not reported
- Hypersensitivity/Allergic reaction
- Reaction
Narrative
Description of Event or Problem
COMPLAINT RECEIVED FORM PATIENT THAT ALLEGES "A PATIENT HAVE A SEVERE ALLERGIC REACTION TO THE SLING". QUESTIONNAIRE NOT RECEIVED FROM CLINICAL AND/OR PATIENT. DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION. NO INDICATION EVENT CAUSED OR CONTRIBUTED TO PERMANENT IMPAIRMENT OR DEATH.