MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-06-11 for TAMPAX PEARL TAMPON, ABSORBENCY/SCENT UNK manufactured by Tambrands Manufacturing, Inc..
[22046417]
Presumptive diagnosis of toxic shock syndrome as no other diagnosis could be made [toxic shock syndrome]. Low blood pressure was dangerously low, blood pressure was in the 40's, used vasopressor agents [hypotension]. Nausea, felt like she might throw up [nausea]. Vomiting [vomiting]. Diarrhea [diarrhea]. Fever, temperature went from 97 f to 103 f in 4 1/2 hours [pyrexia]. Swelling face [swelling face]. Became very pale [pallor]. Swelling hands [oedema peripheral]. Suspected urinary tract infection [urinary tract infection]. Urine culture showed may have had (urinary tract infection) [culture urine positive]. Kidneys may have been affected by (urinary tract infection) [renal disorder]. Oxygen saturation values in the low 80s [oxygen saturation decreased]. Felt a little winded [dyspnoea]. Case description: a mother reported that her adolescent daughter, age (b)(6), used tampax pearl tampon, either lite or regular scent unknown while on her menstrual cycle, last use a tampon from her purse for approximately 5 hrs 40 minutes beginning 01:00 through 06:40 on (b)(6) 2013 and was admitted to the critical care unit and hospitalized for 5 days with a presumptive diagnosis of toxic shock syndrome as no other diagnosis could be made. Her mother reported that her daughter was participating in a high school event where the students were set up in tents and sleeping bags, walking and taking breaks, through the cold night beginning 16:00 on (b)(6) 2013. Her daughter changed her tampon approximately 01:00 on (b)(6) 2013 and was up and dancing with friends, feeling fine as late as 03:00; at 06:00 she started to feel like she may throw up, removed the tampon at 06:40, and lay on the floor of the port-a-potty with vomiting and diarrhea until someone found her at 07:30 and called paramedics. The paramedics called her mother and told her that her daughter's blood pressure was dangerously low. She was transported to the emergency room with diarrhea and vomiting, temperature of 97f and blood pressure in the 40's; she was given 3 liters of iv fluids. About 4 1/2 hours later her temperature went up to 103, she became very pale, and had swelling in her face and hands; they did a urine culture suspecting that her daughter might have a urinary tract infection affecting her kidneys. Mother was thinking maybe it was food poisoning or a stomach bug but as the hours passed, her daughter's symptoms worsened and it appeared that something more was going on; over options of being released with antibiotics, observed for a few hours more at the hospital, or being transferred to (b)(6), she chose the transfer to (b)(6) where her daughter was admitted to the intensive care unit. She was given another 3 liters of iv fluids; a central line was put in, appears that they used vasopressor agents to maintain her blood pressure, and she was on oxygen as her o2 saturations were in the low 80's; she was started on a triple antibiotic therapy of rocephin, clindamycin, and vancomycin. Several cultures came back negative and she was transferred out of the intensive care unit on (b)(6) 2013 and released from the hospital on (b)(6) 2013. She had a follow-up with her pediatrician today, (b)(6) 2013, and her daughter is feeling about 80% better but still feeling a little bit winded; all of the doctors believe that she will make a full recovery and she has been cleared to return to school; her pediatrician and the doctors at (b)(6) hospital said the same thing: "we have made a presumptive diagnosis of toxic shock syndrome based on the fact that we cannot make any other diagnosis". Her mother stated that her daughter has worn tampons probably 80% of the time and now knows that she cannot wear tampons; in about a month or so there will be additional testing on her to see if there are any other risk factors that could have precipitated the presumptive diagnosis. The case outcome was improved with windedness, unknown for culture urine positive and oxygen saturation values; recovered for all other symptoms. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[22323410]
Product lot number was not provided by reporter therefore unable to proceed with a lot check. Actual product used discarded. Product samples from sample package remaining and requested product sample return. Reason that the device has not been evaluated by the manufacturer: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219109-2013-00005 |
| MDR Report Key | 3167292 |
| Report Source | 99 |
| Date Received | 2013-06-11 |
| Date of Report | 2013-05-17 |
| Date Mfgr Received | 2013-05-17 |
| Date Added to Maude | 2013-06-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MGR |
| Manufacturer Street | 6110 CENTER HILL AVE. WINTON HIILL BUSINESS CENTER |
| Manufacturer City | CINCINNATI OH 45224 |
| Manufacturer Country | US |
| Manufacturer Postal | 45224 |
| Manufacturer G1 | TAMBRANDS MANUFACTURING, INC. |
| Manufacturer Street | 2879 HOTEL RD. |
| Manufacturer City | AUBURN ME 04210 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 04210 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TAMPAX PEARL TAMPON, ABSORBENCY/SCENT UNK |
| Generic Name | NONE |
| Product Code | HIL |
| Date Received | 2013-06-11 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TAMBRANDS MANUFACTURING, INC. |
| Manufacturer Address | AUBURN ME 04210 US 04210 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2013-06-11 |