MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,08 report with the FDA on 2007-10-25 for EASI-LAV 1528 manufactured by Avent Sa De R.l. De C.v..
[742556]
A report was received through a foreign distributor that, after a gastric lavage procedure, the doctor could not withdraw the gastric tube from the patient's stomach. The doctor confirmed the situation with a gastric camera which determined that the gastric tube was fit tightly into the stomach junction and esophagus. After the doctor sent air into the stomach, the tube came away easily and could be withdrawn. The patient had submucosal lesion at the bottom of the esophagus in three parts. Additional input from the physician stated that there was too much vacuum that might have resulted in negative pressure inside the stomach. Kimberly-clark has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred. This product incident is documented in the kimberly-clark complaint database.
Patient Sequence No: 1, Text Type: D, B5
[8013913]
The device involved in the incident is not available for evaluation. Two potential lot numbers associated with the incident were cited. The device history records were reviewed. Product met manufacturing specifications. The easi-lav product comes in various french sizes. To consider is if the physician selected the correct french size for the patient. Information from this incident will be included in our product complaint and mdr trend reporting systems. Ongoing analysis of trend information is used to identify the need for additional investigations.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611594-2007-00145 |
| MDR Report Key | 932630 |
| Report Source | 01,06,08 |
| Date Received | 2007-10-25 |
| Date of Report | 2007-10-25 |
| Date of Event | 2007-09-27 |
| Date Mfgr Received | 2007-09-27 |
| Date Added to Maude | 2008-05-01 |
| 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 | SALLY HERRICK |
| Manufacturer Street | 1400 HOLCOMB BRIDGE RD, B200 |
| Manufacturer City | ROSWELL GA 30076 |
| Manufacturer Country | US |
| Manufacturer Postal | 30076 |
| Manufacturer Phone | 7705877244 |
| Manufacturer G1 | AVENT SA DE R.L. DE C.V. |
| Manufacturer Street | CIRCUITO INDUSTIAL NO.40 COLONIA OBRERA |
| Manufacturer City | NOGALES, SONORA CP 94048 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | CP 94048 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EASI-LAV |
| Generic Name | CATHETER (GASTRIC, COLONIC) IRRIGATION |
| Product Code | KDH |
| Date Received | 2007-10-25 |
| Model Number | NA |
| Catalog Number | 1528 |
| 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 | 945565 |
| Manufacturer | AVENT SA DE R.L. DE C.V. |
| Manufacturer Address | NOGALES, SONORA MX CP6404E |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-10-25 |