inforMED
InjuryFPF

WALGREEN COMBINATION

Received Jun 15, 2000 · Event occurred May 1, 2000

Report 1520456-2000-00004 · MDR key 282367

Device

Generic name

Hot Water Bottle

Model number

NA

Catalog number

02091

Lot number

UNK

Product problems

  • Detachment Of Device Component

Patient

UNKNOWN

  • Abdominal Pain
  • Other (for use when an appropriate patient code cannot be identified)
  • Foreign body, removal of
  • Therapy/non-surgical treatment, additional

Narrative

Description of Event or Problem

REPORT RECEIVED FROM A CONSUMER THAT THE ENEMA TIP AND ADAPTER CAME OFF DURING USE AND WAS LODGED INSIDE THE RECTUM. ADDITIONAL INFO WAS REQUESTED AND A LETTER WAS RECEIVED THAT VERIFIED THE ENEMA TIP CAME OFF OF THE TUBING INTERNALLY AND WAS LODGED. THE CONSUMER COULD NOT MANUALLY REMOVE THE PRODUCT INITIALLY. CONSUMER PHONED A HOSP EMERGENCY DEPT AND WAS TOLD THAT THE PRODUCT WOULD HAVE TO BE REMOVED MANUALLY BY A PHYSICIAN OR MAY REQUIRE SURGERY IF THE PRODUCT "WENT PAST THE COLON". THE CONSUMER CAN ONLY WORK WITH NATUROPATHIC PHYSICIANS AND ENERGY HEALING CENTERS AND IS "UNABLE TO TAKE ANY TYPE OF MEDICATIONS BECAUSE CONSUMER'S BODY IS ALLERGIC TO THEM". CONSUMER DID NOT GO TO THE EMERGENCY ROOM. CONSUMER WENT TO BED THAT NIGHT AND "WOKE UP AT 6AM WITH PAIN IN STOMACH AND WITH MUCH GAS BUILD-UP." BY 6:30 AM CONSUMER WAS ABLE TO MANUALLY REMOVE THE PRODUCT. CONSUMER IS "STILL EXPERIENCING PAIN IN THE STOMACH AREA". CONSUMER CONTINUES TO "WORK WITH NATURAL DOCTORS TO HELP THE HEALING PROCESS". NO ADDITIONAL INFO WAS AVAILABLE.

Remedial action

  • Other