MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-07-19 for EASI-LAV CLOSED GASTRIC LAVAGE SYSTEM 1534 manufactured by Ballard Medical Products.
[16718329]
Facility contacted kimberly-clark and stated that they had a pt in the er, went to use the product to save the pt's life and this item was missing the lavage tube. The pt did die, although the hospital cannot say if the missing part played a role. The customer was contacted on june 18, 2007; however, they did not want to file any paperwork on the incident at their end. It was a case of suicide and they did not want to provide the company, or any other people with additional information. It was confirmed that the customer had the uncontaminated sample of opened package without tube. Kimberly-clark has no first hand knowledge of the allegations, but is relaying the information received from outside sources pursuant to federal regulations.
Patient Sequence No: 1, Text Type: D, B5
[16907502]
The opened device kit which should consist of the following components has been requested to be returned for evaluation: 1 - east-lav pump device; 1 - 3000 ml fluid bag with connecting tube and clamp; 1 - 5000 ml waste bag with connecting tube and clamp; 1 -gastric tube with easi-lok adapter and clamp; 1 - waste bag hanger; 1 - bite block.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611594-2007-00085 |
| MDR Report Key | 882396 |
| Report Source | 06 |
| Date Received | 2007-07-19 |
| Date of Report | 2007-07-18 |
| Date of Event | 2007-06-06 |
| Date Mfgr Received | 2007-06-07 |
| Date Added to Maude | 2007-07-24 |
| 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 | RICHARD WOLFE |
| Manufacturer Street | 1400 HOLCOMB ERIDGE RD |
| Manufacturer City | ROSWELL GA 30076 |
| Manufacturer Country | US |
| Manufacturer Postal | 30076 |
| Manufacturer Phone | 7705878208 |
| Manufacturer G1 | AVENT SA DE R.L. DE C.V. |
| Manufacturer Street | CIRCUITO INDUSTIAL NO.40 COLONIA OBRERA |
| Manufacturer City | NOGALES, SONORA 84048 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 84048 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EASI-LAV CLOSED GASTRIC LAVAGE SYSTEM |
| Generic Name | GASTRIC LAVAGE SYSTEM |
| Product Code | KDH |
| Date Received | 2007-07-19 |
| Catalog Number | 1534 |
| Lot Number | 337506 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 862126 |
| Manufacturer | BALLARD MEDICAL PRODUCTS |
| Manufacturer Address | DRAPER UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2007-07-19 |