MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2009-04-16 for FLEET BAGENEMA 1101 manufactured by Tiger Medical Product.
[17101268]
A (b)(6) used fleet bagenema on (b)(6) 2008 for constipation. The pt reported rectal bleeding and abdominal pain following use. The pt reported that once the clamp was released, the tip of the bagenema "shot up into her intestines. " the pt went to the emergency room where the doctor used an instrument to remove the tip. The pt did not require admission. Expectedness: rectal haemorrhage: unexpected. Abdominal pain: unexpected. According to the product label. F/u ((b)(6) 2009): the company received the pt's medical records. This case is now medically confirmed. Per the emergency room records, the pt had fleet's tip in rectum which was removed by the physician's fingers and with hemostats. The pt was treated and released. Expectedness: rectal haemorrhage: unexpected. Abdominal pain: unexpected. Foreign body trauma: unexpected. According to the product label.
Patient Sequence No: 1, Text Type: D, B5
[17405968]
Consumer had thrown the enema bag away but still had the box. Investigation summary and conclusion: there were no quality incidents, deviations or add'l complaints for fleet bagenema lot# 063031. Lab physical analysis report were reviewed. No deficiencies related to the nature of consumer's report were noted. The complaint narrative refers to the bagenema "tip". This is actually the tapered end of the tubing attached to the enema bag. The tubing is of one piece measuring 60. 5" plus or minus 1. 5%. Exam of the device shows it is extremely unlikely that the tapered tip would or could separate when device is used as directed. The tip protector is a blue pvc cap placed over the tapered end of the enema's tubing. The product carton instructions state to remove the blue protective shield from the enema tip prior to rectal insertion. Investigation concludes the most probably cause to be that the consumer failed to remove the blue sheath protector prior to rectal insertion. When the tubing clamp was released the force created by fluid flowing from the enema bag through the attached tubing forced the blue protective sheath into the consumer's rectum. No quality issues are noted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1111503-2009-00001 |
| MDR Report Key | 2304462 |
| Report Source | 04,05 |
| Date Received | 2009-04-16 |
| Date of Report | 2009-01-26 |
| Date of Event | 2008-10-30 |
| Date Mfgr Received | 2009-03-10 |
| Device Manufacturer Date | 2006-10-01 |
| Date Added to Maude | 2011-10-28 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 4615 MURRAY PL. |
| Manufacturer City | LYNCHBURG VA 24502 |
| Manufacturer Country | US |
| Manufacturer Postal | 24502 |
| Manufacturer Phone | 4345284000 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEET BAGENEMA |
| Product Code | FCE |
| Date Received | 2009-04-16 |
| Catalog Number | 1101 |
| Lot Number | 063031 |
| Device Expiration Date | 2010-10-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TIGER MEDICAL PRODUCT |
| Manufacturer Address | 1 HUAIHAI ZHONG RD LIULIN TOWER, STE 1910 SHANGHAI 20021 CH 20021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-04-16 |