MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2014-08-25 for SNAP WOUND CARE SYSTEM: SNAP FOAM DRESSING KIT SKTJ-F-15X15 manufactured by Spiracur Inc..
[16561161]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008087410-2014-00001 |
| MDR Report Key | 4066322 |
| Report Source | 01,08 |
| Date Received | 2014-08-25 |
| Date of Report | 2014-08-01 |
| Date of Event | 2014-07-31 |
| Date Mfgr Received | 2014-08-01 |
| Date Added to Maude | 2014-09-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LAWRENCE HU |
| Manufacturer Street | 1180 BORDEAUX DRIVE |
| Manufacturer City | SUNNYVALE CA 94089 |
| Manufacturer Country | US |
| Manufacturer Postal | 94089 |
| Manufacturer Phone | 4087015300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SNAP WOUND CARE SYSTEM: SNAP FOAM DRESSING KIT |
| Generic Name | NPWT NON-POWERED SUCTION APPARATUS |
| Product Code | OKO |
| Date Received | 2014-08-25 |
| Model Number | SKTJ-F-15X15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPIRACUR INC. |
| Manufacturer Address | SUNNYVALE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-08-25 |