MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2000-10-12 for ENEMA BAG W/DYNACLAMP - BOXE DYND70100 * manufactured by Productos Medline.
[199363]
Pt was undergoing preparation for colonoscopy when they complained of pain during the procedure. Pt reportedly was admitted for observation and later underwent sigmoid colostomy to repair a rectal tear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030664-2000-00002 |
| MDR Report Key | 300088 |
| Report Source | 05,06,07 |
| Date Received | 2000-10-12 |
| Date of Report | 2000-10-10 |
| Date of Event | 2000-09-06 |
| Date Mfgr Received | 2000-09-13 |
| Date Added to Maude | 2000-10-17 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LARA SIMMONS |
| Manufacturer Street | ONE MEDLINE PL |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8479492639 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENEMA BAG W/DYNACLAMP - BOXE |
| Generic Name | KIT, ENEMA |
| Product Code | FCE |
| Date Received | 2000-10-12 |
| Model Number | DYND70100 |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 290464 |
| Manufacturer | PRODUCTOS MEDLINE |
| Manufacturer Address | PERU 4333 COLNIA SAN RAFAEL NUEVO LAREDO, TAN MX |
| Baseline Brand Name | @ ENEMA BAG W/DYNACLAMP-BOXE |
| Baseline Generic Name | KIT, ENEMA |
| Baseline Model No | DYND70100 |
| Baseline ID | ENEMA KIT |
| Baseline Device Family | DN72 |
| Baseline Shelf Life [Months] | NA |
| 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; 2. Required No Informationntervention | 2000-10-12 |