MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2010-05-26 for TAMPAX PEARL TAMPON, SUPER SCENT UNKNOWN (NOT APPLICABLE) TAMPON 1 APPLIC manufactured by Tambrands Manufacturing, Inc..
[1610435]
Toxic shock syndrome [toxic shock syndrome]. Fatigue [fatigue]. Weakness [asthenia]. Fever [pyrexia]. Sunburn type rash on feet moving up legs [rash erythematous]. Felt awful [feeling abnormal]. Case description: a consumer reported that they, an adult female age unspecified, used tampax pearl tampon, super scent unk 1 application once only and was diagnosed with toxic shock syndrome by her regular physician on (b) (6)2010. She had noticed a sunburn type rash on her feet, moving up her legs, and felt really awful with fever, fatigue and weakness. Treatment: unspecified antibiotic injection, steroids, and clindamycin. The case outcome was unk. Other product used previously without incident: yes - have used tampax tampon since they came out. No further info was provided.
Patient Sequence No: 1, Text Type: D, B5
[8616909]
Lot number or product was not provided by the rptr therefore, unable to proceed with batch retain testing or product investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219109-2010-00003 |
| MDR Report Key | 1730132 |
| Report Source | 04 |
| Date Received | 2010-05-26 |
| Date of Report | 2010-05-14 |
| Date of Event | 2010-05-07 |
| Date Mfgr Received | 2010-05-14 |
| Date Added to Maude | 2010-06-25 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Street | 6110 CENTER HILL AVE, WINTON HILL BUSINESS CTR |
| 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, SUPER SCENT UNKNOWN (NOT APPLICABLE) TAMPON 1 APPLIC |
| Generic Name | NONE |
| Product Code | HIL |
| Date Received | 2010-05-26 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TAMBRANDS MANUFACTURING, INC. |
| Manufacturer Address | AUBURN ME US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-05-26 |