MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-02-09 for ANDERSEN AN 21.00 AN21 manufactured by Andersen Products, Inc..
[176916]
2 intestinal tubes, miller-abbott type, from the same lot ruptured while in the pts. The pts sustained no ill effect and passed the mercury used in the tubes through normal body waste. The facility returned the remainder of the tubes from that lot to the mfr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1053825-2000-00001 |
| MDR Report Key | 263343 |
| Report Source | 05,06 |
| Date Received | 2000-02-09 |
| Date of Report | 1999-07-14 |
| Date of Event | 1993-04-05 |
| Date Mfgr Received | 1993-04-05 |
| Device Manufacturer Date | 1992-06-01 |
| Date Added to Maude | 2000-02-22 |
| 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 | STEPHANIE WISSINGER |
| Manufacturer Street | 3202 CAROLINE DR HEALTH SCIENCE PARK |
| Manufacturer City | HAW RIVER NC 27258 |
| Manufacturer Country | US |
| Manufacturer Postal | 27258 |
| Manufacturer Phone | 3363763000 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANDERSEN |
| Generic Name | INTESTINAL TUBE |
| Product Code | KDH |
| Date Received | 2000-02-09 |
| Model Number | AN 21.00 |
| Catalog Number | AN21 |
| Lot Number | 925533 |
| ID Number | NA |
| Device Expiration Date | 1997-06-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 254939 |
| Manufacturer | ANDERSEN PRODUCTS, INC. |
| Manufacturer Address | 3202 CAROLINE DR. HEALTH SCIENCE PARK HAW RIVER NC 27258 US |
| Baseline Brand Name | ANDERSEN |
| Baseline Generic Name | INTESTINAL TUBE |
| Baseline Model No | AN 21.00 |
| Baseline Catalog No | AN21 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-02-09 |