SNAP WOUND CARE SYSTEM: SNAP FOAM DRESSING KIT
Received Aug 25, 2014 · Event occurred Jul 31, 2014
Report 3008087410-2014-00001 · MDR key 4066322
Device
Product problems
- Patient-Device Incompatibility
- Compatibility Problem
Patient
Not reported
- Hypersensitivity/Allergic reaction
- Wheal(s)
Narrative
Description of Event or Problem
ON (B)(6) 2014, SPIRACUR INC. RECEIVED DETAILS OF AN EVENT INVOLVING A REPORTED ALLERGENIC REACTION TO THE SNAP FOAM DRESSING KIT COMPONENT OF THE SNAP WOUND CARE SYSTEM. DETAILS OF THE EVENT, WHICH OCCURRED IN (B)(6), ARE PROVIDED BELOW. ON (B)(6) 2014, A PT BEING TREATED FOR A DEHISCED SURGICAL WOUND ON THE ABDOMEN HAD THE SNAP WOUND CARE SYSTEM PLACED WITH A SNAP FOAM DRESSING KIT. IT WAS REPORTED THAT AFTER THE FIRST APPLICATION, THE PT'S SKIN REDDENED WHERE THE HYDROCOLLOID DRESSING WAS PLACED. THE TREATING PHYSICIAN PROTECTED THE PT'S SKIN BY APPLYING THE HYDROCOLLOID DRESSING OVER A FILM DRESSING, AND CONTINUED TREATMENT WITH THE SNAP SYSTEM. AFTER THIS SECOND APPLICATION, IT WAS REPORTED THAT THE PT'S SKIN BECAME RED AND SWOLLEN. THE PHYSICIAN REPORTED THE PT'S SKIN SYMPTOMS SUBSIDED FOLLOWING TREATMENT WITH AN OINTMENT. USING OINTMENT AS A COATING AGENT ALONG WITH THE FILM DRESSINGS, THE PHYSICIAN HAS REPORTED THE SKIN HAS BEEN PROTECTED AND THE ISSUE HAS RESOLVED, AND THE PHYSICIAN HAS ELECTED TO CONTINUE TREATMENT WITH THE SNAP SYSTEM. THE PHYSICIAN REPORTED THERAPY IS ONGOING AND THE WOUND IS IMPROVING.