MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-11-08 for WALGREENS PREMIUM COMBINATION DOUCHE AND ENEMA 02806WG manufactured by Apothecary Products, Llc.
[91361239]
The enema pipe was incorrectly attached to the tubing without the adapter. The root cause could not be definitively determined.
Patient Sequence No: 1, Text Type: N, H10
[91361240]
User stated that while using the enema, the tip came loose and went inside of her. User went to the emergency room where they did an x-ray and gave her morphine before they were finally able to retrieve it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002183416-2017-00001 |
| MDR Report Key | 7010255 |
| Report Source | CONSUMER |
| Date Received | 2017-11-08 |
| Date of Report | 2017-10-04 |
| Date of Event | 2017-10-01 |
| Date Mfgr Received | 2017-10-04 |
| Date Added to Maude | 2017-11-08 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | RUSS DAVIES |
| Manufacturer Street | 11750 12TH AVE S. |
| Manufacturer City | BURNSVILLE MN 55337 |
| Manufacturer Country | US |
| Manufacturer Postal | 55337 |
| Manufacturer Phone | 9528088365 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALGREENS PREMIUM COMBINATION DOUCHE AND ENEMA |
| Generic Name | DOUCHE AND ENEMA |
| Product Code | FCE |
| Date Received | 2017-11-08 |
| Returned To Mfg | 2017-10-31 |
| Model Number | 02806WG |
| Lot Number | 322KB04 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APOTHECARY PRODUCTS, LLC |
| Manufacturer Address | 11750 12TH AVE S. BURNSVILLE MN 55337 US 55337 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-11-08 |