146-S MAPLE LEAF, SMALL

Description of Event or Problem

A MAPLE LEAF¿ (146-S) WAS FITTED ON A PATIENT ON, OR AROUND, (B)(6) 2018 AT (B)(6) HOSPITAL LOS ANGELES(LA). THE ORTHOTIC BRACE WAS ADJUSTED FOR RANGE OF MOTION, ROTATION, AND FLEXION ON, OR AROUND, (B)(6) 2018. ON (B)(6) 2018, A PRESSURE ULCER WAS NOTED ON THE BACK EDGE OF THE RIGHT THIGH CUFF OF THE MAPLE LEAF¿. THE PATIENT WAS WEARING THE ORTHOTIC BRACE CONTINUOUSLY FROM THE FITTING OF THE BRACE UNTIL THE DISCOVERY OF THE PRESSURE ULCER. THE PATIENT WAS FITTED WITH THE ORTHOTIC BRACE TO STABILIZE A REPAIRED FRACTURE AND WAS IN MULTIPLE LAYING, SUPINE, PRONE, AND RECUMBENT POSITIONS DURING THEIR INPATIENT AND OUTPATIENT STAYS.

Additional Manufacturer Narrative

A REVIEW OF ALL RETURN, COMPLIANT, AND FEEDBACK INFORMATION ON THE MAPLE LEAF¿ FOR THE PAST SEVEN YEARS WAS CONDUCTED AND NO OTHER SUCH NARRATIVE WAS DOCUMENTED. THERE WERE ZERO INSTANCES OF PRESSURE ULCERS, TIGHTNESS, OR FIT ISSUES IN ANY OF THE OTHER CASES OF THE MAPLE LEAF BEING USED. I WAS INSTRUCTED BY (B)(6) TO ADD A NARRATIVE THAT THIS SUBMISSION WAS NOT WITHIN 5 BUSINESS DAYS OF RECEIPT DUE TO OUR FIRM BEING IN THE ENROLLMENT PROCESS OF ELECTRONIC SUBMISSION. I WAS INSTRUCTED THAT I ERRONEOUSLY SUBMITTED THIS AS A 5 DAY REPORT, I AM SUBMITTING THIS AS A SUPPLEMENTAL MDR AFTER AMENDING THE TYPE OF REPORT TO 30 DAY REPORT. I WAS FURTHER INSTRUCTED TO INCLUDE, IN THE SUPPLEMENTAL SUBMISSION, TEXT IN THE MFR NARRATIVE TO EXPLAIN THAT THE INITIAL SUBMISSION WAS ERRONEOUSLY SUBMITTED AS A 5 DAY REPORT AND THAT THE FIRM WAS NOT REQUIRED TO INITIATE ACTION TO PREVENT AN UNREASONABLE RISK OF SUBSTANTIAL HARM ATTACHMENT: [(B)(4).PDF, (B)(4).PDF, BECKER ORTHOPEDIC ISO 13485 CERTIFICATE EXP 2021.PDF, ILLUSTRATION OF PRODUCT.PDF]

Additional Manufacturer Narrative

A REVIEW OF ALL RETURN, COMPLIANT, AND FEEDBACK INFORMATION ON THE MAPLE LEAF¿ FOR THE PAST SEVEN YEARS WAS CONDUCTED AND NO OTHER SUCH NARRATIVE WAS DOCUMENTED. THERE WERE ZERO INSTANCES OF PRESSURE ULCERS, TIGHTNESS, OR FIT ISSUES IN ANY OF THE OTHER CASES OF THE MAPLE LEAF BEING USED. I WAS "INSTRUCTUED" BY (B)(6) TO ADD A NARRATIVE THAT THIS SUBMISSION WAS NOT WITHIN 5 BUSINESS DAYS OF RECEIPT DUE TO OUR FIRM BEING IN THE ENROLLMENT PROCESS OF ELECTRONIC SUBMISSION. (B)(4).

Description of Event or Problem

A MAPLE LEAF¿ (146-S) WAS FITTED ON A PATIENT ON, OR AROUND, (B)(6) 2018 AT (B)(6) HOSPITAL (B)(6). THE ORTHOTIC BRACE WAS ADJUSTED FOR RANGE OF MOTION, ROTATION, AND FLEXION ON, OR AROUND, (B)(6) 2018, (B)(6) 2018, AND (B)(6) 2018. ON (B)(6) 2018, A PRESSURE ULCER WAS NOTED ON THE BACK EDGE OF THE RIGHT THIGH CUFF OF THE MAPLE LEAF¿. THE PATIENT WAS WEARING THE ORTHOTIC BRACE CONTINUOUSLY FROM THE FITTING OF THE BRACE UNTIL THE DISCOVERY OF THE PRESSURE ULCER. THE PATIENT WAS FITTED WITH THE ORTHOTIC BRACE TO STABILIZE A REPAIRED FRACTURE AND WAS IN MULTIPLE LAYING, SUPINE, PRONE, AND RECUMBENT POSITIONS DURING THEIR INPATIENT AND OUTPATIENT STAYS.