FDA.reportPublic FDA data

MAUDE MDR 2577048

MDR report key
2577048
Report number
1221538-2009-00013
Event key
0
Event type
3
Date of event
2009-10-20
Date received
2009-12-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
NANCY ROYALTY, DIRECTOR
Address
ONE POST OFFICE SQUARE ACTON MA 01720 US
Phone
888-888-8885
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ALLEN TRANSFER BOARDTRANFER BOARDALLEN MEDICALFMRA-83001-A1A-83001NAR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-12-080

Event Narratives#

D

Patient 1

ON (B)(6) 2009, ALLEN RECEIVED A COPY OF A VOLUNTARY MEDWATCH REPORT ((B)(4)) FROM THE (B)(6) FOR AN (B)(6) EVENT. A PATIENT RECEIVED A FOUR-INCH LONG CUT ON THEIR BACK AS A RESULT OF THEIR USE OF A TRANSFER BOARD WITH A BROKEN END CAP. THE PATIENT WAS TREATED FOR THE WOUND. THERE WERE NO PERMANENT DISABILITIES OR LONG-TERM INJURIES REQUIRING TREATMENT.

N

Patient 1

ALLEN CONTACTED THE REPORTER, (B)(6) RISK MANAGER (B)(6), TO INVESTIGATE. SHE PROVIDED THE NAME AND NUMBER FOR (B)(6) OF SAFE PATIENT HANDLING AT THE VA TO DETERMINE IF THE DAMAGED END CAP WOULD BE MADE AVAILABLE OR IF THEY COULD BE PHOTOGRAPHED. (B)(6) SAID THAT FOLLOWING THE INCIDENT, EIGHT TRANSFER BOARDS WITH BROKEN END CAPS WERE TAKEN OUT OF USE AND THE CAPS REPLACED. THEY HAVE SINCE BEEN RETURNED TO SERVICE, HE SAID. A RETURN SALES ORDER WITH A SHIPPING LABEL WAS ISSUED TO (B)(6) SO THAT THE END CAPS COULD BE RETURNED FOR EVALUATION, BUT THE COMPONENTS WERE NEVER RECEIVED BY ALLEN.