MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-01-04 for manufactured by .
[19939684]
Since no product was returned to date, batch records were reviewed and no defects were noted. Based on review of the complaint data, there are no other complaints of this nature involving this product. The consumer stated previous use of the product, however, no indication of whether this is the first time the product was used during pregnancy. No conclusion can be reached based on the available information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615332-2007-00001 |
| MDR Report Key | 804739 |
| Report Source | 04 |
| Date Received | 2007-01-04 |
| Date Mfgr Received | 2006-12-06 |
| Date Added to Maude | 2007-01-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 199 GRANDVIEW RD |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9088741000 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | MMS |
| Date Received | 2007-01-04 |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 792237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-01-04 |