| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | DEROYAL ABDOMINAL BINDER | BINDER, ABDOMINAL | DEROYAL GUATEMALA | FSD | A131056 | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-09-26 | 0 | 1. O |
Patient 1
PT DEVELOPED RED, RAISED, ITCHY RASH WERE ABDOMINAL BINDER WAS. THIS FACILITY HAS EXPERIENCED MULTIPLE SIMILAR PROBLEMS WITH THIS DEVICE OVER THE LAST YEAR. THE MFR HAS BEEN CONTACTED AND PRODUCT HAS BEEN PROVIDED TO THE MFR. PTS WITH NO KNOWN ALLERGY TO LATEX ARE AFFECTED. ABDOMINAL SUPPORT S/P C-SECTION.
Patient 1
WE HAVE CONTACTED THE CUSTOMER TO TRY TO SEE IF PRODUCT SAMPLES IS STILL AVAILABLE FOR EVAL BUT IT WAS NOT. INVESTIGATION FINDINGS: THE COMPLAINT SAMPLE WAS NOT RETURNED, NO MFG DEFECT WAS REPORTED. THE BOM FOR THE A131056 WAS PRINTED ALONG WITH LATEX, LABELING. NO RECENT MATERIAL CHANGES HAVE BEEN MADE TO THE MATERIALS, THE LAST DOCUMENT BY ECO (B)(4) IN 2011, ATTACHED. RAW MATERIAL NUMBER (B)(4) MSDS/NPE/COC/LATEX ADDED AS WELL AS A131067. ADD'L MATERIAL TESTING SHOWED NO ISSUE WITH THE MATERIAL TO CAUSE IRRITATION. CORRECTION: NONE REQUIRED. ROOT CAUSE ANALYSIS: UNABLE TO DETERMINE, SEVERAL FACTORS MAY CAUSE ALLERGIC REACTIONS INCLUDING PTS OWN SENSITIVITY TO PRESCRIPTIONS/CHEMICALS/MATERIALS/DYES, (OTHER THAN LATEX) AS WELL AS HEAT RELATED RASHES. CORRECTIVE ACTION AND/OR SYSTEMATIC CORRECTION ACTION TAKEN: NO ACTION REQUIRED AT THIS TIME, NO MFG ISSUE WAS FOUND. WILL BE WORKING TOWARDS NOTIFYING THE HOSP OF OUR FINDINGS. NO FURTHER INFO IS AVAILABLE AT THIS TIME. WILL PROVIDE FOLLOW UPS IF INFO BECOMES AVAILABLE.