MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-08-25 for SUPER XL DELIVERY SYSTEM FOR AIR CONTRAST STUDIES 8925 manufactured by E-z-em, Caribe.
[7773393]
Investigation results: 1. Liquid polibar (lot #10636): review of the mfg records for the product lot in question revealed the batch was produced in accordance with mfg and packaging procedures. Nothing unusual pertaining to the nature of this complaint was noted. Microbiological and chemical testing of a retain sample revealed all test results to be within the required specs. 2. Super xl enema kit (lot #10178925): review of mfg records revealed all units, sub-assembly parts, and components to be within the established quality requirements. A retain sample from the lot in question was not available. However, inspection of product mfg befored and after the lot did not reveal any defects. It is the opinion of e-z em's med dir that this event represents an anaphylactic type allergic reaction, most likely to the latex gloves that the med personnel were wearing, although a reaction to one of the excipients in the barium can not be ruled out.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2411512-1997-00004 |
| MDR Report Key | 117207 |
| Report Source | 05 |
| Date Received | 1997-08-25 |
| Date of Report | 1997-08-04 |
| Date of Event | 1997-08-01 |
| Date Facility Aware | 1997-08-01 |
| Report Date | 1997-08-04 |
| Date Reported to Mfgr | 1997-08-04 |
| Date Mfgr Received | 1997-08-04 |
| Device Manufacturer Date | 1997-04-01 |
| Date Added to Maude | 1997-09-05 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPER XL DELIVERY SYSTEM FOR AIR CONTRAST STUDIES |
| Generic Name | ENEMA KIT |
| Product Code | FCD |
| Date Received | 1997-08-25 |
| Model Number | NA |
| Catalog Number | 8925 |
| Lot Number | 10178925 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 114945 |
| Manufacturer | E-Z-EM, CARIBE |
| Manufacturer Address | RAMAL 916 BARRIO CERRO GORDO SAN LORENZO PR 00754 US |
| Baseline Brand Name | SUPER XL DELIVERY SYSTEM |
| Baseline Generic Name | EMPTY ENEMA KIT |
| Baseline Model No | NA |
| Baseline Catalog No | 8925 |
| Baseline ID | * |
| Baseline Device Family | CS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 1997-08-25 |