MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-02-08 for LIBBE manufactured by Tiller Mind Body, Inc.
[242367]
Reporter is concerned about the quality control of the composition of the plastic used to make the tubes. They state that at 102 degrees, the tubes in some lots become so soft that the sphincter muscle is able to collapse the tube.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003194 |
| MDR Report Key | 378259 |
| Date Received | 2002-02-08 |
| Date of Report | 2002-02-08 |
| Date Added to Maude | 2002-02-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIBBE |
| Generic Name | RECTAL TUBE |
| Product Code | GBT |
| Date Received | 2002-02-08 |
| Model Number | NA |
| Catalog Number | NI |
| Lot Number | 123504 |
| ID Number | NA |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 367306 |
| Manufacturer | TILLER MIND BODY, INC |
| Manufacturer Address | 10911 WEST AVE SAN ANTONIO TX 782131537 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-02-08 |