MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2004-12-02 for SURGICAL OB PACK 88841 manufactured by Avent Sa De De C.v..
[17106764]
A hosp reported that a newborn infant "lost a large amount of blood" when the umbilical cord clamp, that was applied, did not close properly. No pt injury or medical intervention were reported. Kimberly-clark corp. Has no first hand knowledge of the allegations but is relaying info rec'd from outside sources pursuant to federal regulations.
Patient Sequence No: 1, Text Type: D, B5
[17238699]
The umbilical cord clamp is one component of kimberly-clark's surgical ob pack. The cord clamp is contract manufactured for kimberly-clark corp. An unused cord clamp (new) is reportedly being returned to kimberly-clark (avent sa de cv), by the hosp, for eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611594-2004-00050 |
| MDR Report Key | 801383 |
| Report Source | 06 |
| Date Received | 2004-12-02 |
| Date of Report | 2004-12-02 |
| Date of Event | 2004-11-08 |
| Date Mfgr Received | 2004-11-12 |
| Device Manufacturer Date | 2004-09-01 |
| Date Added to Maude | 2007-01-09 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | LARRY KLUDT |
| Manufacturer Street | 1400 HOLCOMB BRIDGE RD |
| Manufacturer City | ROSWELL GA 30076 |
| Manufacturer Country | US |
| Manufacturer Postal | 30076 |
| Manufacturer Phone | 7705878279 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGICAL OB PACK |
| Generic Name | UMBILICAL CORD CLAMP |
| Product Code | HFW |
| Date Received | 2004-12-02 |
| Model Number | NA |
| Catalog Number | 88841 |
| Lot Number | AA425901B |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 788926 |
| Manufacturer | AVENT SA DE DE C.V. |
| Manufacturer Address | CAMINO DE LIBRAMIENTO, KM1.5 NOGALES, SONORA MX |
| Baseline Brand Name | SURGICAL OB PACK |
| Baseline Generic Name | SURGICAL PACK |
| Baseline Model No | NA |
| Baseline Catalog No | 88841 |
| Baseline Device Family | SURGICAL PACKS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K842115 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-12-02 |