N
Patient 1
THE BILL OF MATERIAL FOR THE COMPONENTS OF THE PRODUCT WAS REVIEWED AND NO MATERIAL CHANGES TO THE COMPONENTS WERE IDENTIFIED FOR THE LOT NUMBER REPORTED. FURTHERMORE, THE PRODUCT DOES NOT CONTAIN NATURAL RUBBER LATEX.
MAUDE MDR 3246844
- MDR report key
- 3246844
- Report number
- 3005225477-2013-00012
- Event key
- 0
- Event type
- 3
- Date of event
- 2013-07-01
- Date received
- 2013-07-18
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Address
- 200 DEBUSK LANE POWELL TN 37849 US
- Phone
- 865-865-8659
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | DEROYAL | MHW - DRESSING, COMPRESSION | DEROYAL GUATEMALA | MHW | A131067 | 31981358 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-07-18 | 0 | 1. O |
Event Narratives#
D
Patient 1
ABDOMINAL BINDER CAUSED MACULOPAPULAR RASH ON PT'S SKIN. BINDER REMOVED. PT REQUIRED BENADRYL AND HYDROCORTISONE. THIS FACILITY HAS HAD MORE THAN SIX SIMILAR EVENTS WITH THIS PRODUCT IN THE LAST FIVE MONTHS. PRODUCT STATES LATEX FREE. THE FACILITY REPORTS THIS TYPE OF REACTION HAS BEEN IN PTS WITH C-SECTION AS WELL AS VAGINAL DELIVERIES; THUS, STAFF DO NOT BELIEVE THAT THERE IS A REACTION TO THE SKIN PREP USED FOR C-SECTION DELIVERIES BECAUSE THE PREP IS NOT USED IN A VAGINAL DELIVERY. ALSO, STAFF HAVE STATED IN PREVIOUS INCIDENTS THAT THE RASH OCCURS ON AREAS WHICH DOES NOT HAVE THE SKIN PREP BUT DOES HAVE CONTACT WITH THE BINDER.