MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2001-10-04 for ADULT LUMBAR PUNCTURE TRAY 20X3 1/2 4301C manufactured by Allegiance Healthcare Corp..
[217723]
Dr states that circumstances of manometer is not right which is causing a non measurement of pressure and caused leakage of fluid which caused pt to experience post headache symptoms causing pt stay to exceed approximately 3hrs then going to er. Spoke with rn who confirmed above statement. She was not sure what type of additional medication or intervention, other than observation, was required as a result of the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2001-00236 |
| MDR Report Key | 354745 |
| Report Source | 06 |
| Date Received | 2001-10-04 |
| Date of Report | 2001-10-04 |
| Date of Event | 2001-09-05 |
| Date Mfgr Received | 2001-09-06 |
| Device Manufacturer Date | 2001-07-01 |
| Date Added to Maude | 2001-10-10 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | PATRICIA SHARPE-GREGG |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475784148 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADULT LUMBAR PUNCTURE TRAY 20X3 1/2 |
| Generic Name | PROCEDURE TRAY |
| Product Code | IQE |
| Date Received | 2001-10-04 |
| Model Number | 4301C |
| Catalog Number | 4301C |
| Lot Number | L1J007 |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 343965 |
| Manufacturer | ALLEGIANCE HEALTHCARE CORP. |
| Manufacturer Address | 1500 WAUKEGAN RD. MCGAW PARK IL 60085 US |
| Baseline Brand Name | LUMBAR PUNCTURE TRAY |
| Baseline Generic Name | LUMBAR PUNCTURE |
| Baseline Model No | 4301C |
| Baseline Catalog No | 4301C |
| Baseline ID | NA |
| Baseline Device Family | PROCEDURE TRAY |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-10-04 |