MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-12-15 for ALWAYS DISCREET LINER VERY LIGHT REGULAR LENGTH manufactured by Procter & Gamble, Inc..
[5140806]
Anaphylactic shock [anaphylactic shock] gasping for air [dyspnoea] tongue swelling, ballooned to size of mouth [swollen tongue] throat swelling [pharyngeal oedema] lost voice [aphonia] itch-female genital [pruritus genital] hives on crotch the size of a dime [urticaria] lip swelling [lip swelling]. Case description: a consumer reported that they, a female age unspecified, tried always discreet liner, very light regular length and was treated in the emergency room when she went into anaphylactic shock and was gasping for air after using the product for three days. She reported that she began to itch while using discreet on the thirst day. She awoke at 04:00 with hives the size of a dime on her crotch; she removed the liner and in about an hour, she had lost her voice and her throat, tongue, and lips had begun to swell. She stated that by the time she reached the emergency room, she was gasping for air, her tongue had ballooned to the size of her mouth, and she had gone into anaphylactic shock. She was given several doses of epinephrine and prednisone and most of the swelling had gone down during the 4 hours at the emergency room. The consumer was discharged to home and reported that she was not on a regime of prednisone and benadryl for the next few days. The case outcome was improved. Past medical history included: allergy - not prone to allergies. No further info was provided.
Patient Sequence No: 1, Text Type: D, B5
[12641435]
A product lot number was provided by the reporter. A lot check was requested and pening. Customer relations requested product samples return via email on 10/29/2014.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8022168-2014-00003 |
| MDR Report Key | 4332700 |
| Report Source | 04 |
| Date Received | 2014-12-15 |
| Date of Report | 2014-10-27 |
| Date Mfgr Received | 2014-10-27 |
| Date Added to Maude | 2014-12-23 |
| 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 | , REGULATORY AFFAIRS, FEM |
| Manufacturer Street | 6110 CENTER HILL AVE WINTON BUSINESS CTR |
| Manufacturer City | CINCINNATI OH 45224 |
| Manufacturer Country | US |
| Manufacturer Postal | 45224 |
| Manufacturer G1 | PROCTER & GAMBLE, INC. |
| Manufacturer Street | 355 UNIVERSITY AVE. |
| Manufacturer City | BELLEVILLE, ONTARIO K8N5E9 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | K8N5E9 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALWAYS DISCREET LINER VERY LIGHT REGULAR LENGTH |
| Generic Name | NONE |
| Product Code | NRC |
| Date Received | 2014-12-15 |
| Lot Number | 96613817 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROCTER & GAMBLE, INC. |
| Manufacturer Address | BELLEVILLE, ONTARIO CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-12-15 |