MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1997-05-08 for HOLLISTER "PLASTIBELL" SIZE 1.2CM UNK manufactured by Hollister, Inc..
[60163]
During post-partum ob visit @ pt's home r/n noticed swelling of penis & scrotum with discoloration of lower extremities. Baby's mother stated infant had not urinated for approx. 36 hrs. Device was still in place. Dr. Was contacted. Infant was seen in drs ofc then admitted to hospital. Ob physician was called. Device removed without difficulty. Infant's lower extremity color returned pink immed. Pt voided after 15 min. Infant had been circumsized 3/26/97. Admitted 3/28 - discharged 4/1/97. Antibiotics given. Diag: cellulitis of penis/scrotum urinary obstruction. 4/18/97 dr believes it was a foreign body reaction (? ) cause. Admission t. 98 highest t. 3/29/97 100.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1921454-1997-00001 |
| MDR Report Key | 89915 |
| Report Source | 06 |
| Date Received | 1997-05-08 |
| Date of Report | 1997-04-14 |
| Date of Event | 1997-03-28 |
| Date Facility Aware | 1997-04-14 |
| Date Reported to FDA | 1997-04-21 |
| Date Reported to Mfgr | 1997-04-21 |
| Device Manufacturer Date | 1994-08-01 |
| Date Added to Maude | 1997-05-13 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOLLISTER "PLASTIBELL" SIZE 1.2CM |
| Generic Name | CIRCUMCISION DEVICE |
| Product Code | FHG |
| Date Received | 1997-05-08 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | 4H08B |
| ID Number | SIZE 1.2CM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 88895 |
| Manufacturer | HOLLISTER, INC. |
| Manufacturer Address | 2000 HOLLISTER DR. LIBERTYVILLE IL 600483781 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1997-05-08 |