MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-11-21 for ALWAYS PAD, VERSION/ABSORBENCY/SCENT UNKNOWN (NOT APPLICABLE) PAD 1 APPLIC manufactured by Procter & Gamble, Inc..
[3041947]
Event verbatim [preferred term] (related symptoms if any separated by commas): rash from pad [rash]. Case description: a consumer reported that her daughter, age unspecified, used always pad, version/absorbency/scent unknown and reported that her daughter developed a rash that became so bad she was admitted to the hospital for approximately 1 week and treated with an unspecified cream. The case outcome was improved. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[10341372]
Lot number was provided by the reporter but product was not available for return therefore batch retain investigation requested and results pending.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8022168-2012-00001 |
| MDR Report Key | 2848251 |
| Report Source | 04 |
| Date Received | 2012-11-21 |
| Date of Report | 2012-10-25 |
| Date Mfgr Received | 2012-10-25 |
| Date Added to Maude | 2012-11-29 |
| 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 Contact | MGR. |
| Manufacturer Street | 6110 CENTER HILL AVE. WINTON HILL 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 PAD, VERSION/ABSORBENCY/SCENT UNKNOWN (NOT APPLICABLE) PAD 1 APPLIC |
| Generic Name | NONE |
| Product Code | HHD |
| Date Received | 2012-11-21 |
| 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 | PROCTER & GAMBLE, INC. |
| Manufacturer Address | BELLEVILLE, ONTARIO CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2012-11-21 |