MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-04-30 for STOMAHESIVE PASTE 183910 manufactured by Convatec.
[396753]
In 1999 staff person performed ostomy care for the client. "the client got glue (stomahesive paste) on client's finger and put iton the stoma site which entered client's stoma. " client file notes the staff person changed and/or emptied the pouch everyday and indicated that there was stool daily in the pouch. Three weeks later, client was transferred to the hospital for a psychiatric evaluaion and was later transferred to a local hospital and then another hospital witha bowel obstructive. Client was told the stoma was 75% occluded and irrigation was performed which dissolved the blockage. On the day the patient placed the stomahesive paste on client's stoma the staff person called the home health agency who advised the staff person to take the patient to the er. This advise with not taken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1049092-2005-00015 |
| MDR Report Key | 597556 |
| Report Source | 06 |
| Date Received | 2005-04-30 |
| Date of Report | 2005-04-29 |
| Date of Event | 1999-06-07 |
| Date Mfgr Received | 1999-08-16 |
| Date Added to Maude | 2005-05-03 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | ADRIENNE MCNALLY |
| Manufacturer Street | 200 HEADQUARTERS PARK DRIVE |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9099042630 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STOMAHESIVE PASTE |
| Generic Name | OSTOMY PASTE |
| Product Code | EZS |
| Date Received | 2005-04-30 |
| Model Number | NA |
| Catalog Number | 183910 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 587384 |
| Manufacturer | CONVATEC |
| Manufacturer Address | 200 HEADQUARTERS PARK DRIVE SKILLMAN NJ 08558 US |
| Baseline Brand Name | STOMAHESIVE PASTE |
| Baseline Generic Name | OSTOMY ACCESSORY |
| Baseline Model No | NA |
| Baseline Catalog No | 183910 |
| Baseline ID | NA |
| Baseline Device Family | OSTOMY POUCH AND ACCESSORIES |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2005-04-30 |