MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-04-20 for CATHETER, RECTAL BALLOON, 12PK 008274-901 manufactured by Acmi Corporation.
[379286]
Cust. Had two of these burst inside pt as they were filling up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124979-2005-00011 |
| MDR Report Key | 594938 |
| Report Source | 07 |
| Date Received | 2005-04-20 |
| Date of Report | 2005-04-20 |
| Date of Event | 2005-03-18 |
| Date Facility Aware | 2005-03-21 |
| Date Added to Maude | 2005-04-26 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | GRACIELA DENIS |
| Manufacturer Street | 136 TURNPIKE ROAD |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 5088042670 |
| Manufacturer G1 | ACMI CORP. |
| Manufacturer Street | 3037 MT. PLEASANT STREET |
| Manufacturer City | RACINE WI 53404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CATHETER, RECTAL BALLOON, 12PK |
| Generic Name | 700 |
| Product Code | GBT |
| Date Received | 2005-04-20 |
| Returned To Mfg | 2005-03-30 |
| Model Number | 008274-901 |
| Catalog Number | 008274-901 |
| Lot Number | * |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 584769 |
| Manufacturer | ACMI CORPORATION |
| Manufacturer Address | * RACINE WI * US |
| Baseline Brand Name | CATHETER, RECTAL BALLOON, 12PK |
| Baseline Generic Name | 700 |
| Baseline Model No | 008274-901 |
| Baseline Catalog No | 008274-901 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-04-20 |