MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-10-01 for STAYFREE MAXI W/WINGS W/COTTONY DRY COVER manufactured by Johnson & Johnson, Inc..
[948938]
Consumer indicated that she used a pad. She went to the emergency room because she could not urinate. Complained of a prolapse. She was treated with a catheter, so she could urinate. She indicated that she went to the doctor one time.
Patient Sequence No: 1, Text Type: D, B5
[8198270]
This report is considered closed unless additional relevant information is received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8022269-2008-00001 |
| MDR Report Key | 1185316 |
| Report Source | 04 |
| Date Received | 2008-10-01 |
| Date of Report | 2008-09-04 |
| Date of Event | 2008-07-31 |
| Date Mfgr Received | 2008-09-04 |
| Date Added to Maude | 2008-10-09 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LORNA-JANE BREMER |
| Manufacturer Street | 199 GRANDVIEW ROAD |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9733850557 |
| Manufacturer G1 | JOHNSON & JOHNSON, INC. |
| Manufacturer Street | 7101 NOTRE DAME ST. EAST |
| Manufacturer City | MONTREAL H1N2GR |
| Manufacturer Country | CA |
| Manufacturer Postal Code | H1N 2GR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STAYFREE MAXI W/WINGS W/COTTONY DRY COVER |
| Generic Name | PAD, MENSTRUAL, SCENTED-DEODORIZED |
| Product Code | NRC |
| Date Received | 2008-10-01 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1223304 |
| Manufacturer | JOHNSON & JOHNSON, INC. |
| Manufacturer Address | MONTREAL CA H1N 2G4 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2008-10-01 |