MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-05-08 for TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNK manufactured by Tambrands Manufacturing, Inc..
[17837573]
Toxic shock syndrome [toxic shock syndrome]. Septic shock [septic shock]. Left leg amputation above the knee/right leg amputation below the knee [leg amputation]. Amputation of fingers on both hands below the second knuckles [finger amputation]. Coma [coma]. Case description: a lawyer reported that their client, a female age (b)(6), used tampax tampon, version/absorbency/scent unk tampon unk and reported the following: toxic shock syndrome beginning in 2010, left leg amputation above the knee/right leg amputation below the knee, amputation of fingers on both hands below the second knuckles. Treatment: surgery for quadruple amputation. The case outcome was unk. No further info was provided. The lawyer provided an article titled "septic shock survivor: hope builds as she battles back" which mentioned their client. The article stated that their client entered into a local hospital in (b)(6) 2010 where she developed a form of septic shock and fell into a coma. She was discharged from the hospital after a quadruple amputation. Additional treatment included intense therapy sessions. The case outcome was recovered/resolved with sequel. No further info was provided.
Patient Sequence No: 1, Text Type: D, B5
[18152206]
Lot number or product was not provided by the reporter; therefore, unable to proceed with batch retain testing or product investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219109-2013-00004 |
| MDR Report Key | 3115635 |
| Report Source | 99 |
| Date Received | 2013-05-08 |
| Date of Report | 2013-04-22 |
| Date of Event | 2010-01-01 |
| Date Mfgr Received | 2013-04-22 |
| Date Added to Maude | 2013-05-24 |
| 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 Street | 6110 CENTER HILL AVE, WINTON HILL BUSINESS CTR. MANAGER |
| 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 TAMPON, VERSION/ABSORBENCY/SCENT UNK |
| Generic Name | NONE |
| Product Code | HIL |
| Date Received | 2013-05-08 |
| Operator | LAY USER/PATIENT |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2013-05-08 |