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MAUDE MDR 1642

MDR report key
1642
Report number
1642
Event key
0
Event type
3
Date of event
1992-10-17
Date received
1992-11-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1JACKSON-PRATT DRAINUNKNOWNV. MUELLERBYHN/ASU 130-1311UNKNOWNNY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11992-11-0401. O

Event Narratives#

D

Patient 1

JACKSON PRATT DRAIN WAS RECHARGED BY NURSING PERSONNEL AT 0600 ON 10/17/92 WITHOUT INCIDENT. SURGEON ATTEMPTED TO REMOVE DRAIN AT 0730 ON 10/17/92. SUDDENLY, AFTER CUTTING THE SUTURES, THERE WAS A "SNAP" SOUND. THE DISTAL END OF THE DRAIN ENTERED THE WOUND AND WAS NOT VISIBLE. THE PATIENT RETURNED TO SURGERY ON 10/17/92. THE ENTIRE RETAINED DRAIN WAS REMOVEDDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.