MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2010-09-15 for RITE AID PREMIUM DOUCHE & ENEMA KIT 02806RA manufactured by Apothecary Products Inc..
[16837403]
On (b)(6) 2008, while using the (b)(4) premium combination douche & enema kit during a self-performed enema procedure, the enema pipe became detached from the hose and became lodged in the pt's rectum. Attempts made to remove the enema pipe were not successful at home, so the pt went to urgent care where the doctor was also unable to remove the enema pipe. The pt was transported to the hospital, where the enema pipe was surgically removed. The pt performing the enema procedure was (b)(6) ((b)(6) now). The complaint reports that the pt had considerable blood loss while the rectal pipe remained lodged.
Patient Sequence No: 1, Text Type: D, B5
[17058749]
Customer feedback, case id (b)(4) was received on (b)(6) 2010, however, the date of the incident was 2. 5 years earlier on (b)(6) 2008. The patient/user was an (b)(6) female who has used this type of product in the past, however, she purchased a "new" combination kit a few days earlier, and this was the initial use of this kit. The customer feedback reports that the enema pipe became detached during a home, self-performed enema procedure. The patient/user reports that attempts to remove the enema at home and at urgent care were not successful, and needed to be surgically removed at a medical center. The device has not, and we are told will not be returned for evaluation so we cannot determine if there is a failure of the device, or if it was not assembled correctly by the patient/user. Apothecary products inc. Has not received any additional similar complaints in the 2. 5 years since the date of the event. A hazard analysis was conducted on 08/27/2010 to review the severity and likelihood of occurrence of harm for this type of incident. Apothecary products inc. Will review the diameter of the enema pipe collar to determine if a modification to the enema pipe collar is required to prevent this type of event from occurring in future.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183416-2010-00001 |
| MDR Report Key | 1838693 |
| Report Source | 04 |
| Date Received | 2010-09-15 |
| Date of Report | 2010-09-15 |
| Date of Event | 2008-02-03 |
| Date Mfgr Received | 2010-08-17 |
| Device Manufacturer Date | 2007-08-01 |
| Date Added to Maude | 2010-09-22 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JAMES JENKINS |
| Manufacturer Street | 11750 12TH AVE SOUTH |
| Manufacturer City | BURNSVILLE MN 55337 |
| Manufacturer Country | US |
| Manufacturer Postal | 55337 |
| Manufacturer Phone | 9528088364 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RITE AID PREMIUM DOUCHE & ENEMA KIT |
| Generic Name | DOUCHE AND ENEMA KIT |
| Product Code | FCE |
| Date Received | 2010-09-15 |
| Model Number | 02806RA |
| Catalog Number | 02806RA |
| Lot Number | 218BB2 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APOTHECARY PRODUCTS INC. |
| Manufacturer Address | 11750 12TH AVE SOUTH BURNSVILLE MN 55337 US 55337 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2010-09-15 |