MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 1997-03-14 for STOMAHESIVE PASTE 183910 manufactured by Convatec, A B-ms Co..
[44226]
Paste applied to ileostomy 4 1/2 days post-surgery "liquidfied within 30 minutes of application," pt experienced "burning sensation, redness immediately bordering stoma. " visiting nurse discontinued paste, but pouching difficulties, stool leakage continued. Et nurse changed pouching to convex, customer is improving. Customer's father noted she had presented with pouching difficulties since surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1049092-1997-00001 |
| MDR Report Key | 76317 |
| Report Source | 08 |
| Date Received | 1997-03-14 |
| Date of Report | 1997-03-13 |
| Date of Event | 1996-08-05 |
| Date Mfgr Received | 1996-08-15 |
| Date Added to Maude | 1997-03-18 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STOMAHESIVE PASTE |
| Generic Name | OSTOMY PASTE |
| Product Code | EZS |
| Date Received | 1997-03-14 |
| Returned To Mfg | 1996-08-29 |
| Model Number | NA |
| Catalog Number | 183910 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 76055 |
| Manufacturer | CONVATEC, A B-MS CO. |
| Manufacturer Address | 100 HEADQUARTERS PARK DR. 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. Other | 1997-03-14 |