MAUDE MDR 1656524

MDR report key
1656524
Report number
1219109-2010-00002
Event key
0
Event type
3
Date received
2010-04-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
0

Manufacturer Contact#

Contact
LENORE FAULHABER, PHD, MBA, MGR
Address
6110 CENTER HILL AVE. WINTON BUSINESS CENTER CINCINNATI OH 45224 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TAMPAX PEARL TAMPON, ABSORBENCY/SCENT UNK (NA) TAMPON 1 APPLICNONETAMBRANDS MANUFACTURING, INC.HILN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-04-0501. H; 2. L; 3. R

Event Narratives#

D

Patient 1

TOXIC SHOCK SYNDROME [TOXIC SHOCK SYNDROME], TOTAL ORGAN FAILURE [MULTI-ORGAN FAILURE], SUBARACHNOID BLEED [SUBARACHNOID HAEMORRHAGE], MYCOTIC ANEURYSM [MYCOTIC ANEURYSM], BRUISE ON THIGH [CONTUSION], NAUSEA [NAUSEA], VOMITING [VOMITING], MUSCLE ACHES [MYALGIA], HEADACHE [HEADACHE], FEVER OF 103 [PYREXIA], DID NOT HAVE ELEVATED WHITE BLOOD COUNT BUT DID HAVE BANDS PRESENT [BAND NEUTROPHIL COUNT], INFECTIVE ENDOCARDITIS, STAPHYLOCOCCAL ENDOCARDITIS [ENDOCARDITIS STAPHYLOCOCCAL], ECHOCARDIOGRAM SHOWED VEGETATIVE GROWTH ON MITRAL VALVE [ECHOCARDIOGRAM ABNORMAL], HEMOPTYSIS [HAEMOPTYSIS], PLATELETS DROPPED FROM 158 TO 27 [PLATELET COUNT DECREASED], CREATININE IS ELEVATED [BLOOD CREATININE INCREASED], STAPH AUREUS BLOOD CULTURES ALL POSITIVE, BLOOD CULTURES WERE (B) (6). CASE DESCRIPTION: A PHYSICIAN REPORTED THAT HER PT, AN ADULT FEMALE (B) (6), USED A TAMPAX PEARL TAMPON, ABSORBENCY/SCENT UNK, ON (B) (6) 2010, FOR POST COITAL BLEEDING AND WAS ADMITTED TO THE HOSPITAL CRITICAL CARE UNIT ON (B) (6) 2010 AFTER DEVELOPING TOXIC SHOCK SYNDROME AND ULTIMATELY TOTAL ORGAN FAILURE. THE PHYSICIAN WAS NOT SURE HOW LONG THE TAMPON WAS LEFT IN, BUT ON (B) (6) 2010 HER PT DEVELOPED NAUSEA, VOMITING, DIARRHEA, MUSCLE ACHES, HEADACHE AND A FEVER OF 103. SHE HAD PETECHIAE ON ONE TOE AND A BRUISE ON HER THIGH. SHE PRESENTED TO THE EMERGENCY DEPT AND WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL WITH HER FEVER GONE BUT OTHER SYMPTOMS STILL PRESENT. SHE DID NOT HAVE AN ELEVATED WHITE BLOOD COUNT, BUT DID HAVE BANDS PRESENT. AT FIRST SHE WAS THOUGHT TO HAVE MENINGITIS, BUT HER LUMBAR PUNCTURE WAS CLEAR. WITHIN TWO HOURS DURING THE EVENING OF (B) (6) 2010, HER PT DEVELOPED TOTAL ORGAN FAILURE. SHE HAD INFECTIVE ENDOCARDITIS (ECHOCARDIOGRAM SHOWED VEGETATIVE GROWTH ON HER MITRAL VALVE), HEMOPTYSIS, PLATELETS DROPPED FROM 158 TO 27, HER CREATININE WAS ELEVATED. SINCE THE ONE WEEK SHE HAS BEEN HOSPITALIZED, SHE HAS HAD A MYCOTIC ANEURYSM AND SUBARACHNOID BLEED. SIX CULTURES CAME BACK POSITIVE FOR STREP. THE PHYSICIAN FELT AS IF THE PT WAS GOING TO DIE. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. NO FURTHER INFO WAS PROVIDED. ON (B) (6) 2010, EXTERNAL MEDICAL CONSULTANT F/U PHONE CALL TO REPORTING PHYSICIAN: THE PHYSICIAN REPORTED THAT THE BLOOD CULTURES WERE ALL POSITIVE FOR STAPH AUREUS, NOT STREP. HER PT HAS STAPHYLOCOCCAL ENDOCARDITIS. PAST MEDICAL HISTORY INCLUDED AN UNSPECIFIED GYNECOLOGICAL PROCEDURE IN (B) (6) 2010. NO FURTHER INFO WAS PROVIDED. ON (B) (6) /2010: SAFETY F/U PHONE CALL TO REPORTING PHYSICIAN: THE PHYSICIAN REPORTED THAT HER PT'S STAPH WENT INTO AN INFECTIVE ENDOCARDITIS. SIX OUT OF SIX BLOOD CULTURES WERE (B) (6). SHE HAD A BLEED INTO HER HEAD, IS ON A VENTILATOR, AND HAD A TRACHEOTOMY TODAY. NO FURTHER INFO WAS PROVIDED.

N

Patient 1

LOT NUMBER AND PRODUCT SAMPLE NOT AVAILABLE (NOT PROVIDED) TO THE PHYSICIAN REPORTING CASE INFO; THEREFORE, UNABLE TO PROCEED WITH BATCH RETAIN TESTING OR PRODUCT INVESTIGATION. REASON THA THE DEVICE HAS NOT BEEN EVALUATED BY THE MFR: TSS. ADD'L INFO: (US) OTC DEVICE.