MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-05 for SUPER XL ENEMA SYSTEM 901203 manufactured by E-z-em Inc..
[72258804]
Reported to patient safety and then to risk that radiology received a batch of bad enema kits. They had gone through 4 kits in the batch and each one used would leak from the balloon seal. When the balloon deflates, it would cause the retention balloon to allow the catheter tip to fall out of the rectum. This would cause the radiology techs to have to insert the enema tip and reinflate the balloon in order to complete their test. The remainder of this lot number was pulled from the shelf and sequestered by risk management. If the manufacture would like the remainder of the kits from this lot they can send the company representative to come obtain the items for their investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068973 |
| MDR Report Key | 6471473 |
| Date Received | 2017-04-05 |
| Date of Report | 2017-03-15 |
| Date of Event | 2017-03-02 |
| Date Added to Maude | 2017-04-07 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | 0 |
| Brand Name | SUPER XL ENEMA SYSTEM |
| Generic Name | ENEMA KIT |
| Product Code | FGD |
| Date Received | 2017-04-05 |
| Model Number | 901203 |
| Catalog Number | 901203 |
| Lot Number | 60015821 |
| ID Number | REF# 901203 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | E-Z-EM INC. |
| Manufacturer Address | 259 PROSPECT PLAINS ROAD MONROE TOWNSHIP NJ 08831 US 08831 |
| Brand Name | SUPER XL ENEMA SYSTEM |
| Generic Name | ENEMA KIT |
| Product Code | FGD |
| Date Received | 2017-04-05 |
| Model Number | 901203 |
| Catalog Number | 901203 |
| Lot Number | 60015821 |
| ID Number | REF# 901203 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | E-Z-EM INC. |
| Manufacturer Address | 259 PROSPECT PLAINS RD. MONROE TOWNSHIP NJ 08831 US 08831 |
| Brand Name | SUPER XL ENEMA SYSTEM |
| Generic Name | ENEMA KIT |
| Product Code | FGD |
| Date Received | 2017-04-05 |
| Model Number | 901203 |
| Catalog Number | 901203 |
| Lot Number | 60015821 |
| ID Number | REF# 901203 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | E-Z-EM INC.: 259 PROSPECT PLAINS RD. |
| Manufacturer Address | MONROE TOWNSHIP NJ 08831 US 08831 |
| Brand Name | SUPER XL ENEMA SYSTEM |
| Generic Name | ENEMA KIT |
| Product Code | FGD |
| Date Received | 2017-04-05 |
| Model Number | 901203 |
| Catalog Number | 901203 |
| Lot Number | 60015821 |
| ID Number | REF# 901203 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | E-Z-EM INC. |
| Manufacturer Address | 259 PROSPECT PLAINS RD. MONROE TOWNSHIP NJ 08831 US 08831 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-05 |